FDA — authorised 29 October 1992
- Application: NDA018841
- Marketing authorisation holder: PFIZER
- Local brand name: DAYPRO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Daypro in United States
FDA authorised Daypro on 29 October 1992
Marketing authorisations
FDA — authorised 31 January 2001
- Application: ANDA075845
- Marketing authorisation holder: PANGEA
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2001
- Application: ANDA075855
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 2001
- Application: ANDA075848
- Marketing authorisation holder: WATSON LABS
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2001
- Application: ANDA075847
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 2001
- Application: ANDA075842
- Marketing authorisation holder: AARXION ANDA HLDING
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2001
- Application: ANDA075850
- Marketing authorisation holder: SANDOZ
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2001
- Application: ANDA075851
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2001
- Application: ANDA075843
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2002
- Application: ANDA075844
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2002
- Application: ANDA075846
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 2002
- Application: ANDA075849
- Marketing authorisation holder: TEVA
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2006
- Application: ANDA075987
- Marketing authorisation holder: CHARTWELL
- Indication: Labeling
- Status: approved
FDA — authorised 4 May 2017
- Application: ANDA208633
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: OXAPROZIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA217927
- Marketing authorisation holder: SOLUBIOMIX
- Local brand name: COXANTO
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved SOLUBIOMIX's New Drug Application (NDA) 217927 for Daypro on November 21, 2024. This approval allows SOLUBIOMIX to market Daypro in the United States for labeling. Daypro is a medication used for various purposes, as indicated in its labeling.
Daypro 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 Daypro approved in United States?
Yes. FDA authorised it on 29 October 1992; FDA authorised it on 31 January 2001; FDA authorised it on 31 January 2001.
Who is the marketing authorisation holder for Daypro in United States?
PFIZER holds the US marketing authorisation.