FDA — authorised 30 May 2014
- Application: ANDA078857
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 CELECOXIB in United States
FDA authorised CELECOXIB on 30 May 2014 · 30,665 US adverse-event reports
Marketing authorisations
FDA — authorised 30 May 2014
- Application: ANDA076898
- Marketing authorisation holder: TEVA
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 October 2014
- Application: ANDA202240
- Marketing authorisation holder: LUPIN
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 June 2015
- Application: ANDA204197
- Marketing authorisation holder: APOTEX
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved the application number ANDA204197 from APOTEX for CELECOXIB on 26 February 2025. This approval allows APOTEX to market CELECOXIB in the United States. The indication approved is for labeling, but the specific details of the approved labeling are not provided.
FDA — authorised 21 August 2015
- Application: ANDA204519
- Marketing authorisation holder: ALEMBIC
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 September 2015
- Application: ANDA207446
- Marketing authorisation holder: CIPLA
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA207677
- Marketing authorisation holder: TORRENT
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 February 2016
- Application: ANDA206827
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 March 2016
- Application: ANDA204590
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 April 2017
- Application: ANDA207061
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 January 2018
- Application: ANDA210071
- Marketing authorisation holder: CSPC OUYI
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 2018
- Application: ANDA204776
- Marketing authorisation holder: MICRO LABS
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 May 2018
- Application: ANDA208833
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 November 2019
- Application: ANDA208701
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 February 2020
- Application: ANDA207872
- Marketing authorisation holder: TIANJIN TIANYAO
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 2020
- Application: ANDA211412
- Marketing authorisation holder: YILING
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 May 2020
- Application: NDA212157
- Marketing authorisation holder: SCILEX PHARMS
- Local brand name: ELYXYB
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 13 May 2020
- Application: ANDA213598
- Marketing authorisation holder: NANJING
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 December 2020
- Application: ANDA205129
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 December 2020
- Application: ANDA212925
- Marketing authorisation holder: PANGEA
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 January 2021
- Application: ANDA213301
- Marketing authorisation holder: UNICHEM
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 April 2023
- Application: ANDA212564
- Marketing authorisation holder: YABAO PHARM
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 2025
- Application: ANDA213127
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 July 2025
- Application: ANDA205938
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 July 2025
- Application: NDA211759
- Marketing authorisation holder: CARWIN PHARM ASSOC
- Local brand name: VYSCOXA
- Indication: SUSPENSION — ORAL
- 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: 30,665
Most-reported reactions
- Drug Ineffective — 5,262 reports (17.16%)
- Pain — 3,184 reports (10.38%)
- Fatigue — 3,137 reports (10.23%)
- Arthralgia — 3,102 reports (10.12%)
- Off Label Use — 3,063 reports (9.99%)
- Nausea — 3,059 reports (9.98%)
- Diarrhoea — 2,775 reports (9.05%)
- Vomiting — 2,463 reports (8.03%)
- Headache — 2,320 reports (7.57%)
- Rheumatoid Arthritis — 2,300 reports (7.5%)
CELECOXIB 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 CELECOXIB approved in United States?
Yes. FDA authorised it on 30 May 2014; FDA authorised it on 30 May 2014; FDA authorised it on 29 October 2014.
Who is the marketing authorisation holder for CELECOXIB in United States?
PHARMOBEDIENT holds the US marketing authorisation.