FDA Orange Book · active-ingredient family
Sulindac
Sulindac is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLINORIL · NDA 017911
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLINORILRLD×2 | MERCK | NDA 017911 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULINDAC×2 | RISING | ANDA 073039 | — | Jun 22, 1993 | |
| SULINDAC×2 | ANI PHARMS | ANDA 072973 | — | Feb 28, 1992 | |
| SULINDAC×2 | EPIC PHARMA LLC | ANDA 073262 | — | Sep 06, 1991 | |
| SULINDAC | CHARTWELL RX | ANDA 072712 | — | Aug 30, 1991 | |
| SULINDAC | CHARTWELL RX | ANDA 072713 | — | Aug 30, 1991 | |
| SULINDAC | SUN PHARM INDUSTRIES | ANDA 072050 | AB | Apr 17, 1991 | |
| SULINDAC | SUN PHARM INDUSTRIES | ANDA 072051 | AB | Apr 17, 1991 | |
| SULINDAC×2 | EPIC PHARMA | ANDA 072711 | AB | Mar 25, 1991 | |
| SULINDAC | WATSON LABS | ANDA 071891 | AB | Apr 03, 1990 | |
| SULINDAC | WATSON LABS | ANDA 071795 | AB | Apr 03, 1990 |
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.
Sulindac — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
