FDA Orange Book · active-ingredient family
Flurbiprofen
Flurbiprofen is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ANSAID · NDA 018766
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANSAIDRLD×2 | PHARMACIA AND UPJOHN | NDA 018766 | — | Oct 31, 1988 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLURBIPROFEN×2 | SUN PHARM INDS INC | ANDA 075058 | — | Apr 27, 2001 | |
| FLURBIPROFEN | THERAGEN | ANDA 074560 | — | May 16, 1997 | |
| FLURBIPROFEN×2 | PLIVA | ANDA 074647 | — | Apr 01, 1997 | |
| FLURBIPROFEN×2 | RISING | ANDA 074448 | — | Jul 28, 1995 | |
| FLURBIPROFEN×2 | IVAX SUB TEVA PHARMS | ANDA 074411 | — | May 31, 1995 | |
| FLURBIPROFEN | NEW HEIGHTSRX | ANDA 074431 | — | May 31, 1995 | |
| FLURBIPROFEN×2 | TEVA | ANDA 074405 | — | May 24, 1995 | |
| FLURBIPROFEN×2 | NATCO PHARMA | ANDA 074358 | — | Jun 20, 1994 |
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.
Flurbiprofen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
