FDA.reportPublic FDA data

Application 091370

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo
003IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL25MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-442Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-442Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-443Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-443Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-444Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-444Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-051Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-052Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals IANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-053Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45550ORIG2016-10-14