FDA.reportPublic FDA data

Application 040136

Type
ANDA
Sponsor
AM REGENT

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
0517-0901Hydralazine HydrochlorideHydralazine HydrochlorideAmerican Regent, Inc.ANDACurrent
72572-265Hydralazine HydrochlorideHydralazine HydrochlorideCivica, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29893SUPPL2014-02-28
17749SUPPL2014-02-28
42583ORIG2003-07-30