Orange Book product · Generic (ANDA)
OXCARBAZEPINE
OXCARBAZEPINE
At a glance
Nov 30, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 2022
3 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
OXCARBAZEPINE
Strength
300MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 215332
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXCARBAZEPINE
- 2012OXTELLAR XRBrand (NDA)
NDA 202810 · SUPERNUS PHARMS
- 2001TRILEPTALBrand (NDA)
NDA 021285 · NOVARTIS
- 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
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.
