FDA.reportPublic FDA data

Application 202544

Type
ANDA
Sponsor
GLENMARK 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
68462-840Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-840Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-841Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-841Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-842Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-842Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent