FDA Orange Book · active-ingredient family
Betamethasone dipropionate; clotrimazole
Betamethasone dipropionate; clotrimazole 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:LOTRISONE · NDA 020010
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, lotion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTRISONERLD | MERCK SHARP DOHME | NDA 020010 | — | Dec 08, 2000 | |
| LOTRISONERLD | ORGANON | NDA 018827 | — | Jul 10, 1984 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | GLENMARK SPECLT | ANDA 202894 | — | Oct 30, 2015 | |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 076516 | AB | Jun 16, 2005 | |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | SUN PHARMA CANADA | ANDA 076493 | AB | Jul 28, 2004 | |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | ACTAVIS MID ATLANTIC | ANDA 076002 | AB | Aug 02, 2002 | |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | FOUGERA PHARMS | ANDA 075502 | AB | Jun 05, 2001 | |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | TARO | ANDA 075673 | AB | May 29, 2001 |
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.
Betamethasone dipropionate; clotrimazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
