Orange Book product · Brand (NDA)
TRILEPTAL
OXCARBAZEPINE
At a glance
May 25, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2001
25 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
OXCARBAZEPINE
Strength
300MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 021285
Product number
001
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.
- 2012OXTELLAR XRBrand (NDA)
NDA 202810 · SUPERNUS PHARMS
- 2000TRILEPTALBrand (NDA)
NDA 021014 · NOVARTIS
- 2026OXCARBAZEPINEGeneric (ANDA)
ANDA 209020 · MSN
- 2026OXCARBAZEPINEGeneric (ANDA)
ANDA 218341 · UMEDICA LABS PVT
- 2026OXCARBAZEPINEGeneric (ANDA)
ANDA 220281 · STERANCO HLTHCARE
- 2026OXCARBAZEPINEGeneric (ANDA)
ANDA 219556 · EPIC PHARMA LLC
- 2025OXCARBAZEPINEGeneric (ANDA)
ANDA 207300 · MACLEODS PHARMS LTD
- 2025OXCARBAZEPINEGeneric (ANDA)
ANDA 219241 · AUROBINDO PHARMA LTD
- 2024OXCARBAZEPINEGeneric (ANDA)
ANDA 215796 · RICONPHARMA LLC
- 2024OXCARBAZEPINEGeneric (ANDA)
ANDA 207717 · RUBICON RESEARCH
- 2024OXCARBAZEPINEGeneric (ANDA)
ANDA 218278 · BIOCON PHARMA
- 2024OXCARBAZEPINEGeneric (ANDA)
ANDA 217659 · AJANTA PHARMA LTD
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.
