FDA Orange Book · active-ingredient family
Alclometasone dipropionate
Alclometasone dipropionate is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACLOVATE · NDA 018707
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACLOVATERLD | FOUGERA PHARMS | NDA 018707 | — | Dec 14, 1982 | |
| ACLOVATERLD | FOUGERA PHARMS | NDA 018702 | — | Dec 14, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALCLOMETASONE DIPROPIONATE | GLENMARK PHARMS LTD | ANDA 079227 | — | Jul 30, 2009 | |
| ALCLOMETASONE DIPROPIONATE | GLENMARK PHARMS LTD | ANDA 079061 | — | Jun 23, 2009 | |
| ALCLOMETASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076587 | AB | Sep 15, 2005 | |
| ALCLOMETASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 076884 | AB | Jul 18, 2005 | |
| ALCLOMETASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 076973 | AB | Jul 12, 2005 | |
| ALCLOMETASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076730 | AB | Jul 29, 2004 |
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.
Alclometasone dipropionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
