Orange Book product · Brand (NDA)
DICLEGIS
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
At a glance
Apr 08, 2013
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2013
13 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Strength
10MG;10MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021876
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016BONJESTABrand (NDA)
NDA 209661 · DUCHESNAY
- —BENDECTINBrand (NDA)
NDA 010598 · SANOFI AVENTIS US
- 2023DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217000 · BIONPHARMA
- 2022DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212472 · ACTAVIS LABS FL INC
- 2020DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207825 · PHARMOBEDIENT
- 2017DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208518 · PH HEALTH
- 2016DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205811 · ACTAVIS LABS FL INC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
