FDA — authorised 20 August 2019
- Application: ANDA207677
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
🇺🇸 Celebrex in United States
FDA authorised Celebrex on 20 August 2019
Marketing authorisations
FDA — authorised 18 September 2019
- Application: ANDA204519
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 14 December 2021
- Application: ANDA213301
- Marketing authorisation holder: UNICHEM
- Indication: Labeling
- Status: approved
FDA — authorised 26 February 2025
- Application: ANDA204197
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Celebrex for labeling indications on 2025-02-26. This approval was granted to APOTEX under application number ANDA204197. The approval was not designated as an expedited pathway.
FDA — authorised 7 April 2025
- Application: ANDA204590
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved the application number ANDA204590 for Celebrex, a medication used for labeling indications. This approval was granted to MACLEODS PHARMS LTD on 2025-04-07. The approval was processed through the standard expedited pathway.
Celebrex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Celebrex approved in United States?
Yes. FDA authorised it on 20 August 2019; FDA authorised it on 18 September 2019; FDA authorised it on 14 December 2021.
Who is the marketing authorisation holder for Celebrex in United States?
TORRENT holds the US marketing authorisation.