FDA Orange Book · active-ingredient family
Diclofenac sodium; misoprostol
Diclofenac sodium; misoprostol is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARTHROTEC · NDA 020607
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARTHROTECRLD×2 | PFIZER | NDA 020607 | AB | Dec 24, 1997 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | ZYDUS PHARMS | ANDA 206771 | — | Jun 12, 2023 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | MICRO LABS | ANDA 204355 | AB | Jul 15, 2021 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | YUNG SHIN PHARM | ANDA 205143 | AB | Feb 19, 2020 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | AMNEAL PHARMS | ANDA 203995 | AB | Nov 25, 2016 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | EXELA HOLDINGS | ANDA 200540 | — | Mar 14, 2014 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | SANDOZ | ANDA 200158 | — | May 09, 2013 | |
| DICLOFENAC SODIUM AND MISOPROSTOL×2 | ACTAVIS LABS FL INC | ANDA 201089 | AB | Jul 09, 2012 |
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.
Diclofenac sodium; misoprostol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
