FDA Orange Book · active-ingredient family
Diflorasone diacetate
Diflorasone diacetate is approved as 5 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PSORCON · NDA 020205
5
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, ointment
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PSORCONRLD | TARO PHARMS NORTH | NDA 020205 | — | Nov 20, 1992 | |
| PSORCONRLD | PFIZER | NDA 019260 | — | Aug 28, 1985 | |
| FLORONE E | PFIZER | NDA 019259 | — | Aug 28, 1985 | |
| FLORONE | PFIZER | NDA 017741 | — | Approved Prior to Jan 1, 1982 | |
| PSORCON E | PFIZER | NDA 017994 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIFLORASONE DIACETATE | THE J MOLNER | ANDA 210753 | AB | Jun 12, 2018 | |
| DIFLORASONE DIACETATE | RISING | ANDA 207440 | AB | Feb 27, 2017 | |
| DIFLORASONE DIACETATE | SCIEGEN PHARMS | ANDA 206572 | — | Jul 24, 2015 | |
| DIFLORASONE DIACETATE | ANI PHARMS | ANDA 076263 | — | Dec 20, 2002 | |
| DIFLORASONE DIACETATE | SUN PHARMA CANADA | ANDA 075508 | BX | Apr 24, 2000 | |
| DIFLORASONE DIACETATE | SUN PHARMA CANADA | ANDA 075331 | AB | May 14, 1999 | |
| DIFLORASONE DIACETATE | AVONDALE PHARMS | ANDA 075374 | AB | Apr 27, 1999 | |
| DIFLORASONE DIACETATE | AVONDALE PHARMS | ANDA 075187 | — | Mar 30, 1998 |
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.
Diflorasone diacetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
