FDA Orange Book · active-ingredient family
Sulfadiazine
Sulfadiazine is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SULFADIAZINE · NDA 004122
3
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULFADIAZINERLD | LILLY | NDA 004122 | — | Approved Prior to Jan 1, 1982 | |
| SULFADIAZINE | ABBVIE | NDA 004125 | — | Approved Prior to Jan 1, 1982 | |
| SULFADIAZINE | LEDERLE | NDA 004054 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULFADIAZINE | EPIC PHARMA LLC | ANDA 040091 | — | Jul 29, 1994 | |
| SULFADIAZINE | CHARTWELL MOLECULAR | ANDA 080084 | — | Approved Prior to Jan 1, 1982 | |
| SULFADIAZINE | EVERYLIFE | ANDA 080088 | — | Approved Prior to Jan 1, 1982 | |
| SULFADIAZINERLD | IMPAX LABS | ANDA 080081 | — | 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.
Sulfadiazine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
