FDA — authorised 25 May 2001
- Application: NDA021285
- Marketing authorisation holder: NOVARTIS
- Indication: Type 3 - New Dosage Form
- Status: approved
🇺🇸 OXCARBAZEPINE in United States
FDA authorised OXCARBAZEPINE on 25 May 2001 · 8,237 US adverse-event reports
Marketing authorisations
FDA — authorised 9 October 2007
- Application: ANDA077795
- Marketing authorisation holder: HIKMA
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 2007
- Application: ANDA077794
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 2007
- Application: ANDA077802
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved OXCARBAZEPINE for use in the United States on 17 September 2025. The marketing authorisation was granted to GLENMARK PHARMS LTD. The approval was based on a standard application pathway, and the indication approved is for the drug's labeling. This approval allows GLENMARK PHARMS LTD to market OXCARBAZEPINE in the US.
FDA — authorised 15 November 2007
- Application: ANDA077801
- Marketing authorisation holder: TARO
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2007
- Application: ANDA078005
- Marketing authorisation holder: ANI PHARMS
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2008
- Application: ANDA078069
- Marketing authorisation holder: BRECKENRIDGE PHARM
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 April 2008
- Application: ANDA077747
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2009
- Application: ANDA078734
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 January 2010
- Application: ANDA090239
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2012
- Application: ANDA202961
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 October 2012
- Application: ANDA201193
- Marketing authorisation holder: HIKMA
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 June 2021
- Application: ANDA212428
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 July 2021
- Application: ANDA211420
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 August 2022
- Application: ANDA215726
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 November 2022
- Application: ANDA209652
- Marketing authorisation holder: BIONPHARMA
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 November 2022
- Application: ANDA215332
- Marketing authorisation holder: AUCTA
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 July 2023
- Application: ANDA211747
- Marketing authorisation holder: ZYDUS
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2023
- Application: ANDA213369
- Marketing authorisation holder: APOTEX
- Local brand name: OXCARBAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 October 2023
- Application: ANDA216749
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 February 2024
- Application: ANDA217782
- Marketing authorisation holder: KANCHAN HLTHCARE
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 March 2024
- Application: ANDA218278
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 March 2024
- Application: ANDA207717
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2024
- Application: ANDA213183
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 November 2024
- Application: ANDA215796
- Marketing authorisation holder: RICONPHARMA LLC
- Local brand name: OXCARBAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 April 2025
- Application: ANDA219241
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: OXCARBAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 July 2025
- Application: ANDA207300
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 March 2026
- Application: ANDA219556
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2026
- Application: ANDA220281
- Marketing authorisation holder: STERANCO HLTHCARE
- Local brand name: OXCARBAZEPINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 April 2026
- Application: ANDA218341
- Marketing authorisation holder: UMEDICA LABS PVT
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA218442
- Marketing authorisation holder: BIOCON PHARMA LTD
- Local brand name: OXCARBAZEPINE
- Indication: TABLET — EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA218724
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: OXCARBAZEPINE
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA206576
- Marketing authorisation holder: TWI PHARMS INC
- Local brand name: OXCARBAZEPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA219404
- Marketing authorisation holder: LUPIN LIMITED
- Local brand name: OXCARBAZEPINE EXTENDED RELEASE TABLETS
- Indication: TABLET — EXTENDED RELEASE
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 8,237
Most-reported reactions
- Drug Ineffective — 1,793 reports (21.77%)
- Seizure — 1,233 reports (14.97%)
- Off Label Use — 983 reports (11.93%)
- Drug Interaction — 677 reports (8.22%)
- Dizziness — 676 reports (8.21%)
- Fatigue — 660 reports (8.01%)
- Fall — 578 reports (7.02%)
- Hyponatraemia — 565 reports (6.86%)
- Nausea — 541 reports (6.57%)
- Headache — 531 reports (6.45%)
OXCARBAZEPINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is OXCARBAZEPINE approved in United States?
Yes. FDA authorised it on 25 May 2001; FDA authorised it on 9 October 2007; FDA authorised it on 9 October 2007.
Who is the marketing authorisation holder for OXCARBAZEPINE in United States?
NOVARTIS holds the US marketing authorisation.