Orange Book product · Generic (ANDA)
CARBAMAZEPINE
CARBAMAZEPINE
At a glance
Jun 05, 2002
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 05, 2002
24 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBAMAZEPINE
Strength
100MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 075714
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 217277 · ALKEM LABS LTD
- 2025CARBAMAZEPINEGeneric (ANDA)
ANDA 212524 · TORRENT
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.
