FDA.reportPublic FDA data

Application 201524

Type
ANDA
Sponsor
LUPIN 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; HYDROCHLOROTHIAZIDEIRBESARTAN; HYDROCHLOROTHIAZIDETABLET; ORAL300MG; 25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
68180-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-413Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-414Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent