FDA Orange Book · active-ingredient family
Triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)
Triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole) is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SULTRIN · NDA 005794
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULTRIN×2 | ORTHO MCNEIL PHARM | NDA 005794 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VAGILIA | COSETTE | ANDA 088821 | — | Nov 09, 1987 | |
| GYNE-SULF | COSETTE | ANDA 088607 | — | Jun 09, 1986 | |
| TRIPLE SULFA | FOUGERA | ANDA 088463 | — | Jan 03, 1985 | |
| TRIPLE SULFA | PHARMADERM | ANDA 088462 | — | Jan 03, 1985 | |
| TRIPLE SULFA | PADAGIS US | ANDA 087285 | — | Nov 15, 1982 | |
| TRIPLE SULFA | ALPHARMA US PHARMS | ANDA 087864 | — | Sep 01, 1982 | |
| TRYSUL | SAVAGE LABS | ANDA 087887 | — | Jul 23, 1982 | |
| TRIPLE SULFA | FOUGERA | ANDA 086424 | — | 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.
Triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole) — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
