FDA.reportPublic FDA data

Application 088468

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2514Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2514Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-2514Hydralazine HydrochlorideHydralazine HydrochlorideA-S Medication SolutionsANDACurrent
50111-328Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-328Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-328Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
50111-328Hydralazine HydrochlorideHydralazine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
51079-076Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-076Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-076Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
51079-076Hydralazine HydrochlorideHydralazine HydrochlorideMylan Institutional Inc.ANDACurrent
55154-1487HydralazineHydralazineCardinal HealthANDACurrent
55154-1487HydralazineHydralazineCardinal HealthANDACurrent
55154-1490HydralazineHydralazineCardinal HealthANDACurrent
55154-1490HydralazineHydralazineCardinal HealthANDACurrent
55154-5085Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-5085Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-5085Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
63739-127Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-127Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-127Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson CorporationANDACurrent
65084-127Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba RX PakANDACurrent
65084-127Hydralazine HydrochlorideHydralazine HydrochlorideMcKesson Corporation dba RX PakANDACurrent
70518-1868Hydralazine HydrochlorideHydralazine HydrochlorideREMEDYREPACK INC.ANDACurrent