FDA.reportPublic FDA data

Application 202870

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;50MGNoNo
002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;100MGNoNo
003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL50MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-669Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
13811-670Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
13811-671Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideTrigen Laboratories, LLCANDACurrent
46708-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-115Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-116Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-117Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7331Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7332Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7332Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideBryant Ranch PrepackANDACurrent