Orange Book product · Generic (ANDA)
CARBAMAZEPINE
CARBAMAZEPINE
At a glance
Jan 14, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBAMAZEPINE
Strength
100MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 217277
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CARBAMAZEPINE
- 2016CARNEXIVBrand (NDA)
NDA 206030 · LUNDBECK PHARMS LLC
- 2004EQUETROBrand (NDA)
NDA 021710 · VALIDUS PHARMS
- 1997CARBATROLBrand (NDA)
NDA 020712 · TAKEDA PHARMS USA
- 1996TEGRETOL-XRBrand (NDA)
NDA 020234 · NOVARTIS
- 1987TEGRETOLBrand (NDA)
NDA 018927 · NOVARTIS
- —TEGRETOLBrand (NDA)
NDA 018281 · NOVARTIS
- —TEGRETOLBrand (NDA)
NDA 016608 · NOVARTIS
- 2025CARBAMAZEPINEGeneric (ANDA)
ANDA 219939 · ALEMBIC
- 2025CARBAMAZEPINEGeneric (ANDA)
ANDA 216623 · ALEMBIC
- 2025CARBAMAZEPINEGeneric (ANDA)
ANDA 219072 · YICHANG HUMANWELL
- 2025CARBAMAZEPINEGeneric (ANDA)
ANDA 212524 · TORRENT
- 2024CARBAMAZEPINEGeneric (ANDA)
ANDA 215664 · OSMOTICA PHARM US
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.
