FDA Orange Book · active-ingredient family
Nitrofurazone
Nitrofurazone is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACTIN-N · NDA 017343
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, dressing, ointment, powder, solution
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FURACIN | SHIRE | ANDA 083789 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | AMBIX | ANDA 086077 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | LANNETT | ANDA 084393 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | PERRIGO NEW YORK | ANDA 084968 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | SUN PHARMA CANADA | ANDA 086156 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | WENDT | ANDA 086766 | — | Approved Prior to Jan 1, 1982 | |
| FURACIN | SHIRE | ANDA 083791 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | PERRIGO NEW YORK | ANDA 085130 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURAZONE | WENDT | ANDA 087081 | — | 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.
Nitrofurazone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
