FDA.reportPublic FDA data

Application 091351

Type
ANDA
Sponsor
LUPIN 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
68180-193Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-193Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-193Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-194Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-194Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-194Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-195Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-195Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-195Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent