FDA.reportPublic FDA data

Application 020727

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIDILHYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATETABLET;ORAL37.5MG;20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-010BiDilHydralazine hydrochloride and Isosorbide dinitrateArbor Pharmaceuticals, Inc.NDACurrent
24338-010BiDilHydralazine hydrochloride and Isosorbide dinitrateArbor Pharmaceuticals, Inc.NDACurrent
24338-010BiDilHydralazine hydrochloride and Isosorbide dinitrateAzurityNDACurrent
24338-010BiDilHydralazine hydrochloride and Isosorbide dinitrateArbor Pharmaceuticals, Inc.NDACurrent
52536-006isosorbide dinitrate and hydralazine hydrochloridehydralazine hydrochloride and isosorbide dinitrateWilshire PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67571SUPPL2021-05-21
67556SUPPL2021-05-19
57993SUPPL2019-03-14
57977SUPPL2019-03-13
13304SUPPL2015-04-07
3218SUPPL2015-04-03
13303SUPPL2013-04-01
25648SUPPL2013-03-29
20884ORIG2006-06-21
35242ORIG2005-06-24
3217ORIG2005-06-24