FDA — authorised 20 June 1950
- Application: NDA007073
- Marketing authorisation holder: PFIZER
- Local brand name: AZULFIDINE EN-TABS
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Azulfidine En-Tabs in United States
FDA authorised Azulfidine En-Tabs on 20 June 1950
Marketing authorisations
FDA — authorised 20 June 1950
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
FDA — authorised 12 November 1973
- Application: ANDA080197
- Marketing authorisation holder: CHARTWELL
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 April 1974
- Application: ANDA083450
- Marketing authorisation holder: SOLVAY
- Local brand name: S.A.S.-500
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 1981
- Application: ANDA087197
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 1983
- Application: ANDA086184
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 1987
- Application: ANDA089590
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2000
- Application: NDA021243
- Marketing authorisation holder: PHARMACIA UPJOHN
- Local brand name: AZULFIDINE EN-TABS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2002
- Application: ANDA040349
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2002
- Application: ANDA075339
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: SULFASALAZINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 August 2013
- Application: ANDA085828
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA219046
- Marketing authorisation holder: RISING
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088052
- Marketing authorisation holder: WATSON LABS
- Local brand name: SULFASALAZINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA089339
- Marketing authorisation holder: SUPERPHARM
- Local brand name: SULFASALAZINE
- Indication: TABLET — ORAL
- Status: approved
Azulfidine En-Tabs 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 Azulfidine En-Tabs approved in United States?
Yes. FDA authorised it on 20 June 1950; FDA authorised it on 20 June 1950; FDA authorised it on 12 November 1973.
Who is the marketing authorisation holder for Azulfidine En-Tabs in United States?
PFIZER holds the US marketing authorisation.