FDA Orange Book · active-ingredient family
Amcinonide
Amcinonide is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CYCLOCORT · NDA 019729
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYCLOCORTRLD | ASTELLAS | NDA 019729 | — | Jun 13, 1988 | |
| CYCLOCORTRLD×2 | ASTELLAS | NDA 018116 | — | Approved Prior to Jan 1, 1982 | |
| CYCLOCORTRLD | ASTELLAS | NDA 018498 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMCINONIDE | GENUS LIFESCIENCES | ANDA 076065 | AB | May 15, 2003 | |
| AMCINONIDE | TARO PHARM INDS | ANDA 076367 | — | Mar 19, 2003 | |
| AMCINONIDE | GENUS | ANDA 076096 | — | Nov 19, 2002 | |
| AMCINONIDE | SOLUBIOMIX | ANDA 076329 | — | Nov 06, 2002 | |
| AMCINONIDE | TARO PHARM INDS | ANDA 076229 | AB | May 31, 2002 |
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.
Amcinonide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
