FDA.report

Application 201662

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;80MGNoNo
002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;160MGNoNo
003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;320MGNoNo
004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;160MGNoNo
005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;320MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-453Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-453Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-454Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-454Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-455Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-455Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-456Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-456Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-457Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-457Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
50090-3292Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3485Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3485Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3485Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3485Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4839Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4839Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4872Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4872Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4883Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4883Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
62332-079Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-079Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-079Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-079Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-079Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-080Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-080Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-080Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-080Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-080Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-081Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-081Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-081Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-081Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-081Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-082Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-082Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-082Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-082Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-082Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-083Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-083Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-083Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-083Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-083Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
63187-943Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
63187-943Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
68071-4333Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4333Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4376Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4376Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
71205-015Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-015Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-042Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-042Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71335-0853Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0853Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0853Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent