RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>62332-313-14</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (62332-313-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62332-0313-14</NDC11Code>
    <ProductNDC>62332-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets  are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&amp;C Blue#2 Aluminium Lake, hypromellose, polyethylene glycol 8000, talc, and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-313-28</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (62332-313-28)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62332-0313-28</NDC11Code>
    <ProductNDC>62332-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-313-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62332-313-30) </PackageDescription>
    <NDC11Code>62332-0313-30</NDC11Code>
    <ProductNDC>62332-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets  are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&amp;C Blue#2 Aluminium Lake, hypromellose, polyethylene glycol 8000, talc, and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-143-14</NDCCode>
    <PackageDescription>126 CAPSULE in 1 CARTON (62332-143-14) </PackageDescription>
    <NDC11Code>62332-0143-14</NDC11Code>
    <ProductNDC>62332-143</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204519</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
    <Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white or almost white crystalline powder with a pKa of about 11 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and soluble to freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains propylene glycol, red iron oxide and shellac. 100 mg capsule contains FD &amp; C Blue No. # 2 aluminum lake, propylene glycol and shellac. 200 mg capsule contains propylene glycol, shellac and yellow iron oxide. 400 mg capsule contains FD &amp; C Blue No. # 2 aluminum lake, propylene glycol, shellac, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-314-14</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (62332-314-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62332-0314-14</NDC11Code>
    <ProductNDC>62332-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets  are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&amp;C Blue#2 Aluminium Lake, hypromellose, polyethylene glycol 8000, talc, and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-314-28</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (62332-314-28)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>62332-0314-28</NDC11Code>
    <ProductNDC>62332-314</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>14</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11673-313-58</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11673-313-58)  &gt; 14 g in 1 TUBE</PackageDescription>
    <NDC11Code>11673-0313-58</NDC11Code>
    <ProductNDC>11673-313</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Up And Up Antibiotic Plus Pain Relief</ProprietaryName>
    <NonProprietaryName>Neomycin, Polymyxin B, Pramoxine Hcl</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150409</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333B</ApplicationNumber>
    <LabelerName>Target Corporation</LabelerName>
    <SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>3.5; 10000; 10</StrengthNumber>
    <StrengthUnit>mg/g; [USP'U]/g; mg/g</StrengthUnit>
    <Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection and for temporary relief of pain or discomfort in minor: 1 cuts, 2 scrape , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33342-313-56</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (33342-313-56)  / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>33342-0313-56</NDC11Code>
    <ProductNDC>33342-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Memantine And Donepezil</ProprietaryName>
    <NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208672</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>28; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
    <Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>43419-313-06</NDCCode>
    <PackageDescription>14 g in 1 CONTAINER (43419-313-06)</PackageDescription>
    <NDC11Code>43419-0313-06</NDC11Code>
    <ProductNDC>43419-313</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Iope Retigen Moisture Twin Cake No.17</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>AMOREPACIFIC</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.84; .868; .4116</StrengthNumber>
    <StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-25</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>46708-313-14</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (46708-313-14)  / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>46708-0313-14</NDC11Code>
    <ProductNDC>46708-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Teriflunomide</ProprietaryName>
    <NonProprietaryName>Teriflunomide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209572</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>TERIFLUNOMIDE</SubstanceName>
    <StrengthNumber>7</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.</IndicationAndUsage>
    <Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol 8000, talc, and FD&amp;C Blue#2 Aluminium Lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>55289-313-14</NDCCode>
    <PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (55289-313-14)</PackageDescription>
    <NDC11Code>55289-0313-14</NDC11Code>
    <ProductNDC>55289-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20031023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040525</ApplicationNumber>
    <LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2017-05-23</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>67046-313-14</NDCCode>
    <PackageDescription>14 TABLET in 1 BLISTER PACK (67046-313-14)</PackageDescription>
    <NDC11Code>67046-0313-14</NDC11Code>
    <ProductNDC>67046-313</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171005</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078558</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
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    <PackageDescription>14 mL in 1 TUBE (68479-313-01)</PackageDescription>
    <NDC11Code>68479-0313-01</NDC11Code>
    <ProductNDC>68479-313</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Breakout Clearing Overnight Treatment</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
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    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358H</ApplicationNumber>
    <LabelerName>Dermalogica, Inc.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>for the treatment of acne.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>62332-008-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (62332-008-30) </PackageDescription>
    <NDC11Code>62332-0008-30</NDC11Code>
    <ProductNDC>62332-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
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    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <LastUpdate>2023-09-29</LastUpdate>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
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    <PackageDescription>100 TABLET in 1 BOTTLE (62332-008-31) </PackageDescription>
    <NDC11Code>62332-0008-31</NDC11Code>
    <ProductNDC>62332-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
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    <StartMarketingDate>20151001</StartMarketingDate>
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    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-008-91</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (62332-008-91) </PackageDescription>
    <NDC11Code>62332-0008-91</NDC11Code>
    <ProductNDC>62332-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
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    <StartMarketingDate>20151001</StartMarketingDate>
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    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <LastUpdate>2023-09-29</LastUpdate>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-009-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (62332-009-30) </PackageDescription>
    <NDC11Code>62332-0009-30</NDC11Code>
    <ProductNDC>62332-009</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine</ProprietaryName>
    <NonProprietaryName>Venlafaxine</NonProprietaryName>
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    <ApplicationNumber>ANDA078932</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <LastUpdate>2023-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
  </NDC>
  <NDC>
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    <NDC11Code>62332-0009-31</NDC11Code>
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    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <IndicationAndUsage>Venlafaxine tablets are indicated for the treatment of major depressive disorder.    The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).   A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/ venlafaxine hydrochloride extended release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87. The structural formula is shown below.   Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone.</Description>
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    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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    <IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:  Major Depressive Disorder (MDD) [see Clinical Studies (14.1)]  Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)]  Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)]  Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride extended-release capsules, USP for once-a-day oral administration contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl) ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white or almost white powder, it is freely soluble in methanol and water, soluble in anhydrous ethanol and slightly soluble or practically insoluble in acetone. Its octanol: water partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres (composed of sucrose, corn starch and purified water), talc, povidone (k-30), povidone (k-90), ethyl cellulose and hypromellose. The empty hard gelatin capsule shells contain titanium dioxide, gelatin, iron oxide red and iron oxide yellow. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing shellac, iron oxide red, propylene glycol and simethicone. FDA approved dissolution test specifications differ from USP.</Description>
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    <ApplicationNumber>ANDA217767</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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    <IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:  Major Depressive Disorder (MDD) [see Clinical Studies (14.1)]  Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)]  Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)]  Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride extended-release capsules, USP for once-a-day oral administration contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl) ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white or almost white powder, it is freely soluble in methanol and water, soluble in anhydrous ethanol and slightly soluble or practically insoluble in acetone. Its octanol: water partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres (composed of sucrose, corn starch and purified water), talc, povidone (k-30), povidone (k-90), ethyl cellulose and hypromellose. The empty hard gelatin capsule shells contain titanium dioxide, gelatin, iron oxide red and iron oxide yellow. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing shellac, iron oxide red, propylene glycol and simethicone. FDA approved dissolution test specifications differ from USP.</Description>
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