FDA Orange Book · active-ingredient family
Phenylbutazone
Phenylbutazone 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:BUTAZOLIDIN · NDA 008319
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUTAZOLIDIN×2 | NOVARTIS | NDA 008319 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENYLBUTAZONE | SUN PHARM INDUSTRIES | ANDA 088994 | — | Dec 04, 1985 | |
| PHENYLBUTAZONE | SUN PHARM INDUSTRIES | ANDA 088863 | — | Dec 04, 1985 | |
| PHENYLBUTAZONE | IVAX PHARMS | ANDA 088218 | — | Jun 24, 1983 | |
| PHENYLBUTAZONE | WATSON LABS | ANDA 087756 | — | Dec 17, 1982 | |
| PHENYLBUTAZONE | CHARTWELL RX | ANDA 087774 | — | Jun 16, 1982 | |
| PHENYLBUTAZONE | WATSON LABS | ANDA 087674 | — | Apr 21, 1982 | |
| AZOLID | SANOFI AVENTIS US | ANDA 087260 | — | Approved Prior to Jan 1, 1982 | |
| AZOLID | SANOFI AVENTIS US | ANDA 087091 | — | Approved Prior to Jan 1, 1982 | |
| PHENYLBUTAZONE | FOSUN PHARMA | ANDA 084339 | — | Approved Prior to Jan 1, 1982 | |
| PHENYLBUTAZONE | WATSON LABS | ANDA 086151 | — | Approved Prior to Jan 1, 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.
Phenylbutazone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
