FDA.reportPublic FDA data

Application 203010

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;40MGNoNo
002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;80MGNoNo
003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL25MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
62332-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-209Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-210Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-211Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
63629-7854Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7854Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7854Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10145ORIG2014-02-27