FDA Orange Book · active-ingredient family
Selenium sulfide
Selenium sulfide is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SELSUN · NDA 007936
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · lotion/shampoo
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SELSUNRLD | CHATTEM | NDA 007936 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SELENIUM SULFIDE | PADAGIS US | ANDA 089996 | — | Jan 10, 1991 | |
| SELENIUM SULFIDE | PHARMOBEDIENT CNSLTG | ANDA 088228 | — | Sep 01, 1983 | |
| EXSEL | ALLERGAN HERBERT | ANDA 083892 | — | Approved Prior to Jan 1, 1982 | |
| SELENIUM SULFIDE | ACTAVIS MID ATLANTIC | ANDA 084394 | — | Approved Prior to Jan 1, 1982 | |
| SELENIUM SULFIDE | COSETTE | ANDA 086209 | — | Approved Prior to Jan 1, 1982 | |
| SELENIUM SULFIDE | IVAX PHARMS | ANDA 085777 | — | 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.
Selenium sulfide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
