FDA Orange Book · active-ingredient family
Trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine)
Trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) is approved as 3 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEOTRIZINE · NDA 006317
3
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEOTRIZINE×2 | LILLY | NDA 006317 | — | Approved Prior to Jan 1, 1982 | |
| TERFONYL×2 | BRISTOL MYERS SQUIBB | NDA 006904 | — | Approved Prior to Jan 1, 1982 | |
| TRIPLE SULFAS×2 | LEDERLE | NDA 006920 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LANTRISUL | LANNETT | ANDA 080123 | — | Approved Prior to Jan 1, 1982 | |
| SULFALOID | FOREST PHARMS | ANDA 080100 | — | Approved Prior to Jan 1, 1982 | |
| SULFOSE×2 | WYETH AYERST | ANDA 080013 | — | Approved Prior to Jan 1, 1982 | |
| TRIPLE SULFA | ALPHARMA US PHARMS | ANDA 080280 | — | Approved Prior to Jan 1, 1982 | |
| SULFA-TRIPLE #2 | IMPAX LABS | ANDA 080079 | — | Approved Prior to Jan 1, 1982 | |
| SULFALOID | FOREST PHARMS | ANDA 080099 | — | Approved Prior to Jan 1, 1982 | |
| TRIPLE SULFA | PUREPAC PHARM | ANDA 080086 | — | Approved Prior to Jan 1, 1982 | |
| TRIPLE SULFOID | PAL PAK | ANDA 080094 | — | 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.
Trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
