FDA.reportPublic FDA data

Application 090228

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGNoNo
002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-554Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-554Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-554Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-555Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-555Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-555Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USAANDACurrent
69097-972Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideCIPLA USA INC.ANDACurrent
69097-972Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideCIPLA USA INC.ANDACurrent
69097-973Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideCIPLA USA INC.ANDACurrent
69097-973Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideCIPLA USA INC.ANDACurrent