Orange Book product · Brand (NDA)
CARBATROL
CARBAMAZEPINE
At a glance
Sep 30, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CARBAMAZEPINE
Strength
300MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 020712
Product number
002
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.
- 2016CARNEXIVBrand (NDA)
NDA 206030 · LUNDBECK PHARMS LLC
- 2004EQUETROBrand (NDA)
NDA 021710 · VALIDUS PHARMS
- 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
- 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.
