FDA Orange Book · active-ingredient family
Acitretin
Acitretin is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SORIATANE · NDA 019821
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SORIATANERLD×4 | STIEFEL LABS INC | NDA 019821 | — | Oct 28, 1996 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACITRETIN×3 | ALEMBIC | ANDA 217774 | AB | Aug 05, 2024 | |
| ACITRETIN×4 | IMPAX LABS INC | ANDA 202552 | AB | Dec 23, 2015 | |
| ACITRETIN×2 | MYLAN | ANDA 202148 | AB | Sep 10, 2015 | |
| ACITRETIN×2 | MYLAN | ANDA 203707 | — | Sep 10, 2015 | |
| ACITRETIN×4 | SIGMAPHARM LABS LLC | ANDA 204633 | AB | May 22, 2015 | |
| ACITRETIN×2 | BARR LABS INC | ANDA 091455 | AB | Apr 04, 2013 | |
| ACITRETIN×2 | TEVA PHARMS USA | ANDA 202897 | AB | Apr 04, 2013 |
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.
Acitretin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
