FDA Orange Book · active-ingredient family
Flunisolide
Flunisolide is approved as 4 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AEROSPAN HFA · NDA 021247
4
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AEROSPAN HFARLD | PHARMOBEDIENT | NDA 021247 | — | Jan 27, 2006 | |
| NASALIDERLD | IVAX RES | NDA 018148 | — | Approved Prior to Jan 1, 1982 | |
| NASAREL | TEVA BRANDED PHARM | NDA 020409 | — | Mar 08, 1995 | |
| AEROBID | ROCHE PALO | NDA 018340 | — | Aug 17, 1984 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUNISOLIDE | RICONPHARMA LLC | ANDA 207802 | AB | Jun 16, 2022 | |
| FLUNISOLIDE | APOTEX | ANDA 077436 | — | Aug 09, 2007 | |
| FLUNISOLIDE | RISING | ANDA 077704 | AB | Aug 03, 2006 | |
| FLUNISOLIDE | BAUSCH | ANDA 074805 | AB | Feb 20, 2002 |
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.
Flunisolide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
