FDA Orange Book · active-ingredient family
Diflunisal
Diflunisal is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DOLOBID · NDA 018445
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOLOBIDRLD×2 | MERCK | NDA 018445 | — | Apr 19, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIFLUNISAL×3 | HERITAGE PHARMA | ANDA 202845 | — | Aug 16, 2024 | |
| DIFLUNISAL | ZYDUS PHARMS | ANDA 203547 | AB | Jun 16, 2017 | |
| DIFLUNISAL×2 | WATSON LABS | ANDA 074400 | — | Jul 17, 1997 | |
| DIFLUNISAL | ANI PHARMS | ANDA 074604 | — | Jun 10, 1996 | |
| DIFLUNISAL×2 | PUREPAC PHARM | ANDA 074285 | — | May 07, 1996 | |
| DIFLUNISAL | DASTECH INTL | ANDA 073562 | — | Nov 27, 1992 | |
| DIFLUNISAL | DASTECH INTL | ANDA 073563 | — | Nov 27, 1992 | |
| DIFLUNISAL | TEVA | ANDA 073679 | — | Jul 31, 1992 | |
| DIFLUNISAL | TEVA | ANDA 073673 | AB | Jul 31, 1992 |
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.
Diflunisal — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
