Active ingredient
Sulfasalazine
14 finished FDA listings contain Sulfasalazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SULFASALAZINE
- Dosage forms
- Tablet, Tablet, Delayed Release
- Routes
- Oral
- Manufacturers / labelers
- 10
- Strengths listed
- 500 mg/1
- Brand names in FDA listings
- Azulfidine, Azulfidine En-Tabs
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 9524
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 007073 | PFIZER | 1950-06-20 | 8 |
| ANDA 080197 | CHARTWELL | 1973-11-12 | 1 |
| ANDA 085828 | WATSON LABS | 1977-10-21 | 2 |
| ANDA 040349 | NUVO PHARMS INC | 2002-01-11 | 1 |
| ANDA 075339 | NUVO PHARMS INC | 2002-01-11 | 1 |
| ANDA 219046 | RISING | 2025-11-04 | 1 |
Official labeling on DailyMed
- SULFASALAZINE TABLET [MYLAN PHARMACEUTICALS INC.] · version 27 · 2026-08-31
- SULFASALAZINE TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.] · version 31 · 2026-08-31
- AZULFIDINE EN-TABS (SULFASALAZINE) TABLET, DELAYED RELEASE [PFIZER LABORATORIES DIV PFIZER INC] · version 34 · 2026-06-01
- AZULFIDINE (SULFASALAZINE) TABLET [PFIZER LABORATORIES DIV PFIZER INC] · version 28 · 2026-06-01
- SULFASALAZINE TABLET, DELAYED RELEASE [SUNRISE PHARMACEUTICAL, INC.] · version 4 · 2025-12-12
- SULFASALAZINE TABLET [RISING PHARMA HOLDINGS, INC.] · version 1 · 2025-11-17
- SULFASALAZINE TABLET [SUNRISE PHARMACEUTICAL, INC.] · version 4 · 2025-09-17
- SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS] · version 20 · 2025-04-17
- SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS] · version 3 · 2025-04-10
- SULFASALAZINE TABLET [BRYANT RANCH PREPACK] · version 101 · 2024-05-09
- SULFASALAZINE TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 5 · 2023-09-07
- SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] · version 1 · 2023-05-17
Showing the 12 most recent of 13 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.