FDA.reportPublic FDA data

Application 090255

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
004HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-205HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-309HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-309HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-309HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-310HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-310HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-310HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-311HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-311HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-311HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-312HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-312HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-312HydrALAZINE HydrochlorideHydrALAZINE HydrochlorideExelan Pharmaceuticals Inc.ANDACurrent