FDA — authorised 20 June 1950
- Application: NDA007073
- Marketing authorisation holder: PFIZER
- Local brand name: AZULFIDINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Azulfidine in United States
FDA authorised Azulfidine on 20 June 1950
Marketing authorisations
FDA — authorised 29 December 1980
- Application: NDA018605
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: AZULFIDINE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 October 1996
- Application: NDA020465
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: AZULFIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Azulfidine 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 Azulfidine approved in United States?
Yes. FDA authorised it on 20 June 1950; FDA authorised it on 29 December 1980; FDA authorised it on 17 October 1996.
Who is the marketing authorisation holder for Azulfidine in United States?
PFIZER holds the US marketing authorisation.