FDA — authorised 20 June 1950
- Application: NDA007073
- Marketing authorisation holder: PFIZER
- Local brand name: AZULFIDINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Methotrexate-Sulfasalazine-Hydroxychloroquine in United States
FDA authorised Methotrexate-Sulfasalazine-Hydroxychloroquine 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
Other Immunology / Rheumatology approved in United States
Frequently asked questions
Is Methotrexate-Sulfasalazine-Hydroxychloroquine 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 Methotrexate-Sulfasalazine-Hydroxychloroquine in United States?
PFIZER holds the US marketing authorisation.