FDA.reportPublic FDA data

Application 088467

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL25MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2610Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50111-327Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-327Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-327Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-327Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
51079-075Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-075Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-075Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-075Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
55154-5689Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-5689Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-5689Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
63629-8757Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8757Hydralazine HydrochlorideHydralazine HydrochlorideBryant Ranch PrepackANDACurrent
63739-126Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-126Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-126Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson CorporationANDACurrent
65084-126Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba RX PakANDACurrent
65084-126Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba RX PakANDACurrent
67544-657Hydralazine HydrochlorideHydralazine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
70518-0637Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0637Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent