Orange Book product · Generic (ANDA)
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
At a glance
Aug 04, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 2023
2 yr 11 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
ANDA 217000
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
- 2016BONJESTABrand (NDA)
NDA 209661 · DUCHESNAY
- 2013DICLEGISBrand (NDA)
NDA 021876 · DUCHESNAY
- —BENDECTINBrand (NDA)
NDA 010598 · SANOFI AVENTIS US
- 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.
