Doxylamine / pyridoxine Delayed Release Oral Tablet

Brand(s)
Diclegis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Duchesnay Usa, Inc. (2015-01-13)
Oldest Current Product
2013-05-15
License(s)
NDA
RxNORM
DELAYED RELEASE ORAL TABLET\DOXYLAMINE:PYRIDOXINE
FDAOB
ORAL\TABLET, DELAYED RELEASE\DOXYLAMINE SUCCINATE: PYRIDOXINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, DELAYED RELEASE\DOXYLAMINE SUCCINATE: PYRIDOXINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\DOXYLAMINE: PYRIDOXINE

product(s) by strength(s)

doxylamine succinate 10 mg / pyridoxine hydrochloride 10 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1554940100DiclegisNDADuchesnay Usa, Inc.2013-05-15DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDEORALTABLET, DELAYED RELEASENDA0218768bde08f6-e8bd-4e90-baa7-82e01876a86a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021876DICLEGISDUCHESNAY INC2013-04-08p6340695, TREATMETN OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT, SUBSTANCE
p7560122, SUBSTANCE
NEW PRODUCT [2016-04-08]NDA021876_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021876_001RXDOXYLAMINE SUCCINATE (10MG), PYRIDOXINE HYDROCHLORIDE (10MG)ORALTABLET, DELAYED RELEASETrue2013-04-08DICLEGIS

patent(s)

#idexpiration dateapplication(s)
1p6340695 (view patent)2021-06-21NDA021876
2p7560122 (view patent)2019-01-25NDA021876

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
18bde08f6-e8bd-4e90-baa7-82e01876a86a (view SPL)These highlights do not include all the information needed to use DICLEGIS safely and effectively. See full prescribing information for DICLEGIS.Initial U.S. Approval: 1976prescriptionHuman PrescriptionDuchesnay Usa, Inc.2015-01-135554940100

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII