{
"NDC": [
{
"NDCCode": "69790-488-08",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (69790-488-08) ",
"NDC11Code": "69790-0488-08",
"ProductNDC": "69790-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Uline",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180527",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "69790-849-08",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (69790-849-08) ",
"NDC11Code": "69790-0849-08",
"ProductNDC": "69790-849",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Uline",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190719",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease. recommended for repeated use."
},
{
"NDCCode": "11344-488-08",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (11344-488-08) ",
"NDC11Code": "11344-0488-08",
"ProductNDC": "11344-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160527",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "64406-806-01",
"PackageDescription": "1 KIT in 1 KIT (64406-806-01) * 3 mL in 1 VIAL (64406-488-08) * 3 mL in 1 VIAL (64406-035-01)",
"NDC11Code": "64406-0806-01",
"ProductNDC": "64406-806",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Eloctate",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Fc Fusion Protein",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125487",
"LabelerName": "Biogen Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71104-806-01",
"PackageDescription": "1 KIT in 1 KIT (71104-806-01) * 3 mL in 1 VIAL (71104-488-08) * 3 mL in 1 SYRINGE (71104-035-01) ",
"NDC11Code": "71104-0806-01",
"ProductNDC": "71104-806",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Eloctate",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Fc Fusion Protein",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170906",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125487",
"LabelerName": "Bioverativ Therapeutics Inc.",
"Status": "Active",
"LastUpdate": "2023-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170906",
"SamplePackage": "N",
"IndicationAndUsage": "ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Perioperative management of bleeding,, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 3000, 4000, 5000 or 6000 international units (IU). Each vial of ELOCTATE is labeled with the actual content in IU. The powder for injection is reconstituted with 3 mL sterile water for injection (SWFI) supplied in a sterile prefilled syringe. The reconstituted solution should be essentially free of particles. The final product contains the excipients: sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20. ELOCTATE contains no preservatives. B-domain deleted recombinant Factor VIII, Fc fusion protein (BDD-rFVIIIFc) is the active ingredient in ELOCTATE. BDD-rFVIIIFc is a recombinant protein consisting of a B-domain deleted analogue of human Coagulation Factor VIII covalently linked to the human immunoglobulin G1 (IgG1) Fc domain sequence. The Factor VIII portion of the molecule has a 90 kDa heavy chain and an 80 kDa light chain (similar to endogenous Factor VIII), which are linked by 14 (of 908) amino acids from the central B-domain. The FVIII portion has post-translational modifications comparable to endogenous Factor VIII. The Fc domain of the molecule contains the hinge, CH2, and CH3 regions of IgG1. BDD-rFVIIIFc contains 1890 amino acids with an apparent molecular weight of 220 kDa. The majority of the expressed protein is proteolytically processed to a two chain molecule; however, ELOCTATE may also contain up to 39% of a single chain, non-processed form. Both molecules have been shown to have comparable Factor VIII activity. BDD-rFVIIIFc is produced by recombinant DNA technology from a human embryonic kidney (HEK) cell line, which has been extensively characterized. The HEK cell line expresses BDD-rFVIIIFc into a defined, cell culture medium that does not contain any proteins derived from animal or human sources. BDD-rFVIIIFc is purified using a series of chromatography steps, including affinity capture with a recombinant, single chain antibody fragment produced in a yeast expression system. No human or animal derived proteins are used in the purification or formulation processes. The production process also incorporates two dedicated viral clearance steps - a detergent treatment step for inactivation and a 15 nm filtration step for removal of viruses."
},
{
"NDCCode": "71919-488-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-488-08) ",
"NDC11Code": "71919-0488-08",
"ProductNDC": "71919-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natrum Sulphuricum",
"NonProprietaryName": "Sodium Sulfate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SODIUM SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "72024-488-08",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (72024-488-08) ",
"NDC11Code": "72024-0488-08",
"ProductNDC": "72024-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Fastenal",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180527",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "69790-089-33",
"PackageDescription": "50 PACKET in 1 BOX (69790-089-33) > 2 TABLET, CHEWABLE in 1 PACKET",
"NDC11Code": "69790-0089-33",
"ProductNDC": "69790-089",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uline Antacid",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Uline",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "420",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191007",
"SamplePackage": "N"
},
{
"NDCCode": "69790-801-04",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (69790-801-04) ",
"NDC11Code": "69790-0801-04",
"ProductNDC": "69790-801",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uline Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200608",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Uline",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200608",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available."
},
{
"NDCCode": "0480-3523-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56) ",
"NDC11Code": "00480-3523-56",
"ProductNDC": "0480-3523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "0480-3524-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3524-56) ",
"NDC11Code": "00480-3524-56",
"ProductNDC": "0480-3524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "0480-5101-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0480-5101-06) ",
"NDC11Code": "00480-5101-06",
"ProductNDC": "0480-5101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "0480-5102-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0480-5102-06) ",
"NDC11Code": "00480-5102-06",
"ProductNDC": "0480-5102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "0480-5103-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0480-5103-06) ",
"NDC11Code": "00480-5103-06",
"ProductNDC": "0480-5103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "0480-5104-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-5104-56) ",
"NDC11Code": "00480-5104-56",
"ProductNDC": "0480-5104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-599-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-599-60) ",
"NDC11Code": "43598-0599-60",
"ProductNDC": "43598-599",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
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"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-600-60",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-601-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-601-60) ",
"NDC11Code": "43598-0601-60",
"ProductNDC": "43598-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-602-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-602-30) ",
"NDC11Code": "43598-0602-30",
"ProductNDC": "43598-602",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-603-30",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
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"StartMarketingDate": "20250303",
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"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
"StrengthNumber": "100",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "43598-604-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-604-30) ",
"NDC11Code": "43598-0604-30",
"ProductNDC": "43598-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
},
{
"NDCCode": "60505-3628-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (60505-3628-6) ",
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"ProductNDC": "60505-3628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202103",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "60505-3629-6",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202103",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
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"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "60505-3630-6",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202103",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "60505-3631-3",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202103",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "60505-3816-3",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203180",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "60505-3817-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3817-3) ",
"NDC11Code": "60505-3817-03",
"ProductNDC": "60505-3817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203180",
"LabelerName": "Apotex Corp.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration."
},
{
"NDCCode": "67046-1588-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1588-3) ",
"NDC11Code": "67046-1588-03",
"ProductNDC": "67046-1588",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091388",
"LabelerName": "Coupler LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250916",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water. Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68428-488-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-488-03) ",
"NDC11Code": "68428-0488-03",
"ProductNDC": "68428-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Muriatica",
"NonProprietaryName": "Magnesium Chloride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100729",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MAGNESIUM CHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100729",
"SamplePackage": "N"
},
{
"NDCCode": "68428-488-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-488-05) ",
"NDC11Code": "68428-0488-05",
"ProductNDC": "68428-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesia Muriatica",
"NonProprietaryName": "Magnesium Chloride",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100729",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MAGNESIUM CHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100729",
"SamplePackage": "N"
}
]
}
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<NDC>
<NDCCode>69790-488-08</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (69790-488-08) </PackageDescription>
<NDC11Code>69790-0488-08</NDC11Code>
<ProductNDC>69790-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Uline</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69790-849-08</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (69790-849-08) </PackageDescription>
<NDC11Code>69790-0849-08</NDC11Code>
<ProductNDC>69790-849</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Uline</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-488-08</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (11344-488-08) </PackageDescription>
<NDC11Code>11344-0488-08</NDC11Code>
<ProductNDC>11344-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64406-806-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (64406-806-01) * 3 mL in 1 VIAL (64406-488-08) * 3 mL in 1 VIAL (64406-035-01)</PackageDescription>
<NDC11Code>64406-0806-01</NDC11Code>
<ProductNDC>64406-806</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Eloctate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Fc Fusion Protein</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125487</ApplicationNumber>
<LabelerName>Biogen Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71104-806-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (71104-806-01) * 3 mL in 1 VIAL (71104-488-08) * 3 mL in 1 SYRINGE (71104-035-01) </PackageDescription>
<NDC11Code>71104-0806-01</NDC11Code>
<ProductNDC>71104-806</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Eloctate</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Fc Fusion Protein</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170906</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125487</ApplicationNumber>
<LabelerName>Bioverativ Therapeutics Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: 1 On-demand treatment and control of bleeding episodes,, 2 Perioperative management of bleeding,, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-dose vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 3000, 4000, 5000 or 6000 international units (IU). Each vial of ELOCTATE is labeled with the actual content in IU. The powder for injection is reconstituted with 3 mL sterile water for injection (SWFI) supplied in a sterile prefilled syringe. The reconstituted solution should be essentially free of particles. The final product contains the excipients: sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20. ELOCTATE contains no preservatives. B-domain deleted recombinant Factor VIII, Fc fusion protein (BDD-rFVIIIFc) is the active ingredient in ELOCTATE. BDD-rFVIIIFc is a recombinant protein consisting of a B-domain deleted analogue of human Coagulation Factor VIII covalently linked to the human immunoglobulin G1 (IgG1) Fc domain sequence. The Factor VIII portion of the molecule has a 90 kDa heavy chain and an 80 kDa light chain (similar to endogenous Factor VIII), which are linked by 14 (of 908) amino acids from the central B-domain. The FVIII portion has post-translational modifications comparable to endogenous Factor VIII. The Fc domain of the molecule contains the hinge, CH2, and CH3 regions of IgG1. BDD-rFVIIIFc contains 1890 amino acids with an apparent molecular weight of 220 kDa. The majority of the expressed protein is proteolytically processed to a two chain molecule; however, ELOCTATE may also contain up to 39% of a single chain, non-processed form. Both molecules have been shown to have comparable Factor VIII activity. BDD-rFVIIIFc is produced by recombinant DNA technology from a human embryonic kidney (HEK) cell line, which has been extensively characterized. The HEK cell line expresses BDD-rFVIIIFc into a defined, cell culture medium that does not contain any proteins derived from animal or human sources. BDD-rFVIIIFc is purified using a series of chromatography steps, including affinity capture with a recombinant, single chain antibody fragment produced in a yeast expression system. No human or animal derived proteins are used in the purification or formulation processes. The production process also incorporates two dedicated viral clearance steps - a detergent treatment step for inactivation and a 15 nm filtration step for removal of viruses.</Description>
</NDC>
<NDC>
<NDCCode>71919-488-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-488-08) </PackageDescription>
<NDC11Code>71919-0488-08</NDC11Code>
<ProductNDC>71919-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natrum Sulphuricum</ProprietaryName>
<NonProprietaryName>Sodium Sulfate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>SODIUM SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72024-488-08</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (72024-488-08) </PackageDescription>
<NDC11Code>72024-0488-08</NDC11Code>
<ProductNDC>72024-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Fastenal</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69790-089-33</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (69790-089-33) > 2 TABLET, CHEWABLE in 1 PACKET</PackageDescription>
<NDC11Code>69790-0089-33</NDC11Code>
<ProductNDC>69790-089</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uline Antacid</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Uline</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>420</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69790-801-04</NDCCode>
<PackageDescription>3780 mL in 1 BOTTLE, PLASTIC (69790-801-04) </PackageDescription>
<NDC11Code>69790-0801-04</NDC11Code>
<ProductNDC>69790-801</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uline Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200608</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Uline</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0480-3523-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3523-56) </PackageDescription>
<NDC11Code>00480-3523-56</NDC11Code>
<ProductNDC>0480-3523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211094</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S H2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
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<ApplicationNumber>ANDA213383</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>43598-604-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-604-30) </PackageDescription>
<NDC11Code>43598-0604-30</NDC11Code>
<ProductNDC>43598-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213383</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60505-3628-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-3628-6) </PackageDescription>
<NDC11Code>60505-3628-06</NDC11Code>
<ProductNDC>60505-3628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202103</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>60505-3629-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-3629-6) </PackageDescription>
<NDC11Code>60505-3629-06</NDC11Code>
<ProductNDC>60505-3629</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202103</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>60505-3630-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-3630-6) </PackageDescription>
<NDC11Code>60505-3630-06</NDC11Code>
<ProductNDC>60505-3630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202103</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>60505-3631-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-3631-3) </PackageDescription>
<NDC11Code>60505-3631-03</NDC11Code>
<ProductNDC>60505-3631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202103</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>60505-3816-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3) </PackageDescription>
<NDC11Code>60505-3816-03</NDC11Code>
<ProductNDC>60505-3816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203180</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>60505-3817-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-3817-3) </PackageDescription>
<NDC11Code>60505-3817-03</NDC11Code>
<ProductNDC>60505-3817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203180</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with : 1 Ph+ CML in chronic phase., 2 newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2SH2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration.</Description>
</NDC>
<NDC>
<NDCCode>67046-1588-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1588-3) </PackageDescription>
<NDC11Code>67046-1588-03</NDC11Code>
<ProductNDC>67046-1588</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091388</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water. Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68428-488-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-488-03) </PackageDescription>
<NDC11Code>68428-0488-03</NDC11Code>
<ProductNDC>68428-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesia Muriatica</ProprietaryName>
<NonProprietaryName>Magnesium Chloride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100729</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-488-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-488-05) </PackageDescription>
<NDC11Code>68428-0488-05</NDC11Code>
<ProductNDC>68428-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesia Muriatica</ProprietaryName>
<NonProprietaryName>Magnesium Chloride</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100729</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>