FDA — authorised 30 May 2014
- Application: ANDA078857
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CELECOXIB
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 CELBESTA® in United States
FDA authorised CELBESTA® on 30 May 2014
Marketing authorisations
FDA — authorised 29 October 2014
- Application: ANDA202240
- Marketing authorisation holder: LUPIN
- 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 1 February 2016
- Application: ANDA206827
- Marketing authorisation holder: AUROBINDO PHARMA
- 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 14 November 2019
- Application: ANDA208701
- Marketing authorisation holder: CADILA PHARMS LTD
- 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 12 January 2021
- Application: ANDA213301
- Marketing authorisation holder: UNICHEM
- 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
FDA
- Status: approved
CELBESTA® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is CELBESTA® approved in United States?
Yes. FDA authorised it on 30 May 2014; FDA authorised it on 29 October 2014; FDA authorised it on 23 September 2015.
Who is the marketing authorisation holder for CELBESTA® in United States?
PHARMOBEDIENT holds the US marketing authorisation.