FDA.reportPublic FDA data

Application 089098

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-124Hydralazine HydrochlorideHydralazine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50111-397Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-397Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-397Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-397Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent