FDA Orange Book · active-ingredient family
Flunisolide
Flunisolide: 4 brands, 4 generics; first approved Aug 17, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
4
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- AEROSPAN HFARLDPHARMOBEDIENTNDA 0212472006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.078MG/INH AEROSOL, METERED INHALATION Discontinued — - NASALIDERLDIVAX RESNDA 018148—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG/SPRAY SPRAY, METERED NASAL Discontinued — - TEVA BRANDED PHARMNDA 0204091995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.029MG/SPRAY SPRAY, METERED NASAL Discontinued — - ROCHE PALONDA 0183401984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/INH AEROSOL, METERED INHALATION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- FLUNISOLIDERICONPHARMA LLCANDA 2078022022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG/SPRAY SPRAY, METERED NASAL Rx AB - FLUNISOLIDEAPOTEXANDA 0774362007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.029MG/SPRAY SPRAY, METERED NASAL Discontinued — - FLUNISOLIDERISINGANDA 0777042006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG/SPRAY SPRAY, METERED NASAL Rx AB - FLUNISOLIDERSBAUSCHANDA 0748052002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025MG/SPRAY SPRAY, METERED NASAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
42 yr 9 mo ago
Most recent approval
4 yr 5 mo ago
Approvals span 1984–2022 across 8 FDA applications.
Brand (NDA) 450%
Generic (ANDA) 450%
Flunisolide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
