Orange Book product · Brand (NDA)
TEGRETOL
CARBAMAZEPINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CARBAMAZEPINE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 018281
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 1997CARBATROLBrand (NDA)
NDA 020712 · TAKEDA PHARMS USA
- 1996TEGRETOL-XRBrand (NDA)
NDA 020234 · NOVARTIS
- 1987TEGRETOLBrand (NDA)
NDA 018927 · 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.
