FDA.reportPublic FDA data

Application 209661

Type
NDA
Sponsor
DUCHESNAY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BONJESTADOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MG;20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-120BONJESTAdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72520SUPPL2022-11-01
72517SUPPL2022-11-01
70700SUPPL2022-04-05
54673SUPPL2018-06-21
54639SUPPL2018-06-21
49898ORIG2017-09-29
45858ORIG2016-11-09
45855ORIG2016-11-09