FDA Orange Book · active-ingredient family
Sulfamethoxazole
Sulfamethoxazole is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GANTANOL · NDA 013664
2
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANTANOL | ROCHE | NDA 013664 | — | Approved Prior to Jan 1, 1982 | |
| GANTANOL×2 | ROCHE | NDA 012715 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULFAMETHOXAZOLE | BARR | ANDA 087189 | — | Jul 25, 1983 | |
| SULFAMETHOXAZOLE | ASCOT | ANDA 087662 | — | Oct 20, 1982 | |
| SULFAMETHOXAZOLE | HEATHER | ANDA 086163 | — | Approved Prior to Jan 1, 1982 | |
| SULFAMETHOXAZOLE | RISING | ANDA 085844 | — | Approved Prior to Jan 1, 1982 | |
| SULFAMETHOXAZOLE | WATSON LABS | ANDA 086000 | — | Approved Prior to Jan 1, 1982 | |
| SULFAMETHOXAZOLE | WATSON LABS | ANDA 085053 | — | Approved Prior to Jan 1, 1982 | |
| UROBAK | SHIONOGI | ANDA 087307 | — | 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.
Sulfamethoxazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
