FDA Orange Book · active-ingredient family
Sulfasalazine
Sulfasalazine is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AZULFIDINE EN-TABS · NDA 007073
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZULFIDINE EN-TABSRLD×2 | PFIZER | NDA 007073 | AB | Apr 06, 1983 | |
| AZULFIDINE | PHARMACIA AND UPJOHN | NDA 018605 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULFASALAZINE | RISING | ANDA 219046 | AB | Nov 04, 2025 | |
| SULFASALAZINE | NUVO PHARMS INC | ANDA 075339 | AB | Jan 11, 2002 | |
| SULFASALAZINE | NUVO PHARMS INC | ANDA 040349 | AB | Jan 11, 2002 | |
| SULFASALAZINE | SUPERPHARM | ANDA 089339 | — | Oct 26, 1987 | |
| SULFASALAZINE | SUN PHARM INDUSTRIES | ANDA 089590 | — | Oct 19, 1987 | |
| SULFASALAZINE | WATSON LABS | ANDA 088052 | — | May 24, 1983 | |
| S.A.S.-500 | SOLVAY | ANDA 083450 | — | Approved Prior to Jan 1, 1982 | |
| SULFASALAZINE | CHARTWELL | ANDA 080197 | AB | Approved Prior to Jan 1, 1982 | |
| SULFASALAZINE | EPIC PHARMA LLC | ANDA 086184 | — | Approved Prior to Jan 1, 1982 | |
| SULFASALAZINE | WATSON LABS | ANDA 084964 | — | Approved Prior to Jan 1, 1982 | |
| SULFASALAZINE | WATSON LABS | ANDA 085828 | AB | Approved Prior to Jan 1, 1982 | |
| SULFASALAZINE | WATSON LABS | ANDA 087197 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Sulfasalazine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
