{
"NDC": [
{
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"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0008-1) ",
"NDC11Code": "83014-0008-01",
"ProductNDC": "83014-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictrines, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Progesterone, Oxytocin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; PROGESTERONE; OXYTOCIN",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 34",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
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"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
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"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0001-1) ",
"NDC11Code": "83014-0001-01",
"ProductNDC": "83014-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Female Balance",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Caulophyllum Thalictroides, Cimicifuga Racemosa, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Rubus Idaeus, Thyroidinum (bovine), Pituitarum Posterium Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Hepar Sulphuris Calcareum, Oxytocin, Progesterone",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"EndMarketingDate": "20290214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM SULFIDE; OXYTOCIN; PROGESTERONE",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 12; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Oxytocic [EPC], Oxytocin [CS], Plant Proteins [CS], Progesterone [CS], Progesterone [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230321",
"EndMarketingDatePackage": "20290214",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides female hormonogenic balance support. †. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0002-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0002-1) ",
"NDC11Code": "83014-0002-01",
"ProductNDC": "83014-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Adrenal",
"NonProprietaryName": "Glycyrrhiza Glabra, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Aralia Quinquefolia, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Glandula Suprarenalis (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Adrenocorticotrophin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "GLYCYRRHIZA GLABRA; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; AMERICAN GINSENG; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CORTICOTROPIN",
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"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230321",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant, to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides adrenal support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0003-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0003-1) ",
"NDC11Code": "83014-0003-01",
"ProductNDC": "83014-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Caladium Seguinum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230310",
"EndMarketingDate": "20280614",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; DIEFFENBACHIA SEGUINE WHOLE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230310",
"EndMarketingDatePackage": "20280614",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0004-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0004-1) ",
"NDC11Code": "83014-0004-01",
"ProductNDC": "83014-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230216",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue and resets the hypothalamus.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0005-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0005-1) ",
"NDC11Code": "83014-0005-01",
"ProductNDC": "83014-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Immune Support",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Petroselinum Sativum, Capsicum Annuum, Galium Aparine, Hydrastis Canadensis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum (nspc), Phytolacca Decandra, Thyroidinum (bovine), Thymus (bovine Thymus Gland), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; PETROSELINUM CRISPUM WHOLE; CAPSICUM; GALIUM APARINE WHOLE; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS THYMUS; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12",
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"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides immune support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0006-1",
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"NDC11Code": "83014-0006-01",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Thyroid",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin, Rutinic Acid, Iodium, Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Spongia Tosta, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus, Lapis Albus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPRIC ACID; IODINE; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS; CALCIUM HEXAFLUOROSILICATE",
"StrengthNumber": "2; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 12; 12; 15",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
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},
{
"NDCCode": "83014-0007-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0007-1) ",
"NDC11Code": "83014-0007-01",
"ProductNDC": "83014-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus Male Balance",
"NonProprietaryName": "Agnus Castus, Foeniculum Vulgare, Ammonium Bromatum, Fucus Vesiculosus, Lecithin (derived From Egg), Capsicum Annuum, Galium Aparine, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Phytolacca Decandra, Thyroidinum (bovine), Pituitarum Posterium (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Selenium Metallicum, Adrenalinum, Phosphorus, Orchitinum (bovine), Caladium Seguinum, Onosmodium Virginianum",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20231030",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; DIEFFENBACHIA SEGUINE WHOLE; ONOSMODIUM VIRGINIANUM",
"StrengthNumber": "2; 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 18; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "83014-0100-1",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (83014-0100-1) ",
"NDC11Code": "83014-0100-01",
"ProductNDC": "83014-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Weight Loss Support Plus - Glp 1 Booster",
"NonProprietaryName": "Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20260129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Carolinas Weight Loss Institute",
"SubstanceName": "FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; BERBERIS VULGARIS ROOT BARK; CINNAMON; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; FENUGREEK SEED; ASIAN GINSENG; CAPSICUM; TURMERIC; GALIUM APARINE WHOLE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA INTESTINAL MUCOSA; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS",
"StrengthNumber": "2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260129",
"SamplePackage": "N",
"IndicationAndUsage": "Appetite suppressant to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides support for the body's production of GLP 1.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "0008-0045-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-01",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0045-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0045-02",
"ProductNDC": "0008-0045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vinorelbine Tartrate",
"NonProprietaryName": "Vinorelbine Tartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA178408",
"LabelerName": "Wyeth Pharmaceuticals Company",
"SubstanceName": "VINORELBINE TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vinca Alkaloid [EPC],Vinca Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0008-0100-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00008-0100-01",
"ProductNDC": "0008-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besponsa",
"NonProprietaryName": "Inotuzumab Ozogamicin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170818",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761040",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "INOTUZUMAB OZOGAMICIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170818",
"SamplePackage": "N",
"IndicationAndUsage": "BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.",
"Description": "Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0."
},
{
"NDCCode": "0008-0407-03",
"PackageDescription": "1 mL in 1 VIAL (0008-0407-03)",
"NDC11Code": "00008-0407-03",
"ProductNDC": "0008-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Antivenin (micrurus Fulvius)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19670601",
"EndMarketingDate": "20170331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "1",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "0008-0423-03",
"PackageDescription": "1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) ",
"NDC11Code": "00008-0423-03",
"ProductNDC": "0008-0423",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "North American Coral Snake Antivenin (equine)",
"NonProprietaryName": "Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161012",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101099",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)",
"StrengthNumber": "250",
"StrengthUnit": "[arb'U]/10mL",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).",
"Description": "North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol."
},
{
"NDCCode": "0008-0606-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)",
"NDC11Code": "00008-0606-01",
"ProductNDC": "0008-0606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0008-0607-01",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)",
"NDC11Code": "00008-0607-01",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "0008-0607-04",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00008-0607-04",
"ProductNDC": "0008-0607",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-23"
},
{
"NDCCode": "0008-0833-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) ",
"NDC11Code": "00008-0833-03",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-20",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) ",
"NDC11Code": "00008-0833-20",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19971101",
"SamplePackage": "N"
},
{
"NDCCode": "0008-0833-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) ",
"NDC11Code": "00008-0833-21",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0833-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) ",
"NDC11Code": "00008-0833-22",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0836-03",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-0836-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0836-02) ",
"NDC11Code": "00008-0836-03",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>CHASTE TREE FRUIT; FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; CAPSICUM; GALIUM APARINE WHOLE; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; PHYTOLACCA AMERICANA ROOT; THYROID, BOVINE; BOS TAURUS PITUITARY GLAND, POSTERIOR; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENIUM; EPINEPHRINE; PHOSPHORUS; BOS TAURUS TESTICLE; DIEFFENBACHIA SEGUINE WHOLE; ONOSMODIUM VIRGINIANUM</SubstanceName>
<StrengthNumber>2; 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 9; 9; 9; 9; 12; 12; 16; 18; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating. Helps with metabolic tendencies to gain weight, helps to suppress cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides male hormonogenic support.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83014-0100-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (83014-0100-1) </PackageDescription>
<NDC11Code>83014-0100-01</NDC11Code>
<ProductNDC>83014-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Weight Loss Support Plus - Glp 1 Booster</ProprietaryName>
<NonProprietaryName>Foeniculum Vulgare, Ammonium Bromatum, Berberis Vulgaris, Cinnamomum, Fucus Vesiculosus, Lecithin (derived From Egg), Trigonella Foenum-graecum, Panax Ginseng, Capsicum Annuum, Curcuma Longa, Galium Aparine, Hepar Suis, Hypothalamus Suis, Kali Bichromicum, Lac Defloratum, Pancreas Suis, Phytolacca Decandra, Small Intestine (suis), Pituitarum Posterium (bovine), Thyroidinum (bovine), Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Adrenalinum, Phosphorus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Carolinas Weight Loss Institute</LabelerName>
<SubstanceName>FOENICULUM VULGARE FRUIT; AMMONIUM BROMIDE; BERBERIS VULGARIS ROOT BARK; CINNAMON; FUCUS VESICULOSUS; EGG PHOSPHOLIPIDS; FENUGREEK SEED; ASIAN GINSENG; CAPSICUM; TURMERIC; GALIUM APARINE WHOLE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; POTASSIUM DICHROMATE; SKIM MILK; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA INTESTINAL MUCOSA; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, BOVINE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; EPINEPHRINE; PHOSPHORUS</SubstanceName>
<StrengthNumber>2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 9; 9; 9; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Appetite suppressant to control empty feeling in stomach otherwise relieved by eating, helps with metabolic tendencies to gain weight, cravings. Aids in mobilization of fatty tissue, resets the hypothalamus and provides support for the body's production of GLP 1.†. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-0045-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-01</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0045-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0045-02) > 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0045-02</NDC11Code>
<ProductNDC>0008-0045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vinorelbine Tartrate</ProprietaryName>
<NonProprietaryName>Vinorelbine Tartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA178408</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Company</LabelerName>
<SubstanceName>VINORELBINE TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vinca Alkaloid [EPC],Vinca Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0008-0100-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00008-0100-01</NDC11Code>
<ProductNDC>0008-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besponsa</ProprietaryName>
<NonProprietaryName>Inotuzumab Ozogamicin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170818</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761040</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>INOTUZUMAB OZOGAMICIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.</IndicationAndUsage>
<Description>Inotuzumab ozogamicin is a CD22-directed antibody and cytotoxic-drug conjugate (ADC) consisting of 3 components: 1) the recombinant humanized immunoglobulin class G subtype 4 (IgG4) kappa antibody inotuzumab, specific for human CD22, 2) N-acetyl-gamma-calicheamicin that causes double-stranded DNA breaks, and 3) an acid-cleavable linker composed of the condensation product of 4-(4'-acetylphenoxy)-butanoic acid (AcBut) and 3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that covalently attaches N-acetyl-gamma-calicheamicin to inotuzumab. Inotuzumab ozogamicin has an approximate molecular weight of 160 kDa. The average number of calicheamicin derivative molecules conjugated to each inotuzumab molecule is approximately 6 with a distribution from 2–8. Inotuzumab ozogamicin is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the semisynthetic calicheamicin derivative is produced by microbial fermentation followed by synthetic modification. BESPONSA (inotuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous administration. Each single-dose vial delivers 0.9 mg inotuzumab ozogamicin. Inactive ingredients are polysorbate 80 (0.36 mg), sodium chloride (2.16 mg), sucrose (180 mg), and tromethamine (8.64 mg). After reconstitution with 4 mL of Sterile Water for Injection, USP, the final concentration is 0.25 mg/mL of inotuzumab ozogamicin with a deliverable volume of 3.6 mL (0.9 mg) and a pH of approximately 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0008-0407-03</NDCCode>
<PackageDescription>1 mL in 1 VIAL (0008-0407-03)</PackageDescription>
<NDC11Code>00008-0407-03</NDC11Code>
<ProductNDC>0008-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Antivenin (micrurus Fulvius)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19670601</StartMarketingDate>
<EndMarketingDate>20170331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0423-03</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0008-0423-03) > 10 mL in 1 VIAL (0008-0423-01) </PackageDescription>
<NDC11Code>00008-0423-03</NDC11Code>
<ProductNDC>0008-0423</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>North American Coral Snake Antivenin (equine)</ProprietaryName>
<NonProprietaryName>Coral Snake (micrurus Fulvius) Immune Globulin Antivenin (equine)</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161012</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101099</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>[arb'U]/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).</IndicationAndUsage>
<Description>North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized with eastern coral snake (Micrurus fulvius fulvius) venom. Prior to lyophilization, the product contains 0.25% phenol.</Description>
</NDC>
<NDC>
<NDCCode>0008-0606-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0606-01)</PackageDescription>
<NDC11Code>00008-0606-01</NDC11Code>
<ProductNDC>0008-0606</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20170930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-01</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0607-01)</PackageDescription>
<NDC11Code>00008-0607-01</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0607-04</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0607-04) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-0607-04</NDC11Code>
<ProductNDC>0008-0607</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>0008-0833-03</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-0833-03) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0008-0833-02) </PackageDescription>
<NDC11Code>00008-0833-03</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-20</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-20) </PackageDescription>
<NDC11Code>00008-0833-20</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-0833-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) </PackageDescription>
<NDC11Code>00008-0833-21</NDC11Code>
<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
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<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>0008-0836</ProductNDC>
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<EndMarketingDate>20260630</EndMarketingDate>
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<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
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<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
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<NDC11Code>00008-0837-03</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC11Code>00008-0837-20</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
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<ProprietaryName>Effexor</ProprietaryName>
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<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
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<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
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<ProductNDC>0008-0837</ProductNDC>
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<EndMarketingDate>20250531</EndMarketingDate>
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<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, 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 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. 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 cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0841-17</NDCCode>
<PackageDescription>5 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0008-0841-17)</PackageDescription>
<NDC11Code>00008-0841-17</NDC11Code>
<ProductNDC>0008-0841</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-15</LastUpdate>
</NDC>
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