FDA.reportPublic FDA data

Application 203110

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0500Hydralazine HydrochlorideHydralazine HydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0500Hydralazine HydrochlorideHydralazine HydrochlorideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0500Hydralazine HydrochlorideHydralazine HydrochlorideX-GEN Pharmaceuticals, Inc.ANDACurrent
71872-7050Hydralazine HydrochlorideHydralazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10166ORIG2015-07-08