FDA Orange Book · active-ingredient family
Sulfinpyrazone
Sulfinpyrazone 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:ANTURANE · NDA 011556
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANTURANERLD×2 | NOVARTIS | NDA 011556 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULFINPYRAZONE | PAR PHARM | ANDA 088934 | — | Sep 06, 1985 | |
| SULFINPYRAZONE | PAR PHARM | ANDA 088933 | — | Sep 06, 1985 | |
| SULFINPYRAZONE | VANGARD | ANDA 088666 | — | Feb 17, 1984 | |
| SULFINPYRAZONE | IVAX PHARMS | ANDA 087770 | — | Nov 19, 1982 | |
| SULFINPYRAZONE | BARR | ANDA 087666 | — | Sep 17, 1982 | |
| SULFINPYRAZONE | BARR | ANDA 087665 | — | Sep 17, 1982 | |
| SULFINPYRAZONE | IVAX PHARMS | ANDA 087769 | — | Jun 01, 1982 | |
| SULFINPYRAZONE | WATSON LABS | ANDA 087667 | — | May 26, 1982 |
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.
Sulfinpyrazone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
