FDA.reportPublic FDA data

Application 089097

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50111-398Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-398Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-398Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-398Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
51079-074Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-074Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-074Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-074Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
55154-5394Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-5394Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent