FDA.reportPublic FDA data

Application 021876

Type
NDA
Sponsor
DUCHESNAY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLEGISDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDETABLET, DELAYED RELEASE;ORAL10MG;10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
55494-100DICLEGISdoxylamine succinate and pyridoxine hydrochlorideDuchesnay USA, Inc.NDACurrent
63629-8358Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8358Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideAnalog PharmaNDA AUTHORIZED GENERICCurrent
70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideAnalog PharmaNDA AUTHORIZED GENERICCurrent
70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideAnalog PharmaNDA AUTHORIZED GENERICCurrent
70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideAnalog PharmaNDA AUTHORIZED GENERICCurrent
70505-100Doxylamine succinate and pyridoxine hydrochlorideDoxylamine succinate and pyridoxine hydrochlorideAnalog PharmaNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72519SUPPL2022-11-01
72516SUPPL2022-11-01
54672SUPPL2018-06-21
54635SUPPL2018-06-21
28756SUPPL2014-12-17
44656ORIG2014-03-25
21853ORIG2014-03-25
16503SUPPL2013-09-30
16502ORIG2013-04-16
6359ORIG2013-04-10