FDA.reportPublic FDA data

Application 040730

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9875HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9875HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHenry Schein, Inc.ANDACurrent
0404-9986HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideHenry Schein, Inc.ANDACurrent
17478-834Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-834Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-834Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkornANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkornANDACurrent
17478-934Hydralazine HydrochlorideHydralazine HydrochlorideAkorn, Inc.ANDACurrent
51662-1388HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1388HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-112HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-112HYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-934HYDRALAZINE HYDRCHLORIDEHYDRALAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-934HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-934HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-1280Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
55154-1280Hydralazine HydrochlorideHydralazine HydrochlorideCardinal HealthANDACurrent
71872-7051Hydralazine HydrochlorideHydralazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7051Hydralazine HydrochlorideHydralazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7281Hydralazine HydrochlorideHydralazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent