Orange Book product · Brand (NDA)
FLONASE ALLERGY RELIEF
FLUTICASONE PROPIONATE
At a glance
Jul 23, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2014
12 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE
Strength
0.05MG/SPRAY
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 205434
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022ARMONAIR DIGIHALERBrand (NDA)
NDA 208798 · TEVA PHARM
- 2017XHANCEBrand (NDA)
NDA 209022 · PARATEK PHARMS
- 2005CUTIVATEBrand (NDA)
NDA 021152 · FOUGERA PHARMS
- 2004FLOVENT HFABrand (NDA)
NDA 021433 · GLAXO GRP LTD
- 2000FLOVENT DISKUS 100Brand (NDA)
NDA 020833 · GLAXO GRP LTD
- 1997FLOVENTBrand (NDA)
NDA 020549 · GLAXOSMITHKLINE
- 1996FLOVENTBrand (NDA)
NDA 020548 · GLAXOSMITHKLINE
- 1994FLONASEBrand (NDA)
NDA 020121 · HALEON US HOLDINGS
- 1990CUTIVATEBrand (NDA)
NDA 019958 · FOUGERA PHARMS
- 1990CUTIVATEBrand (NDA)
NDA 019957 · FOUGERA PHARMS
- 2026FLUTICASONE PROPIONATEGeneric (ANDA)
ANDA 218742 · GLENMARK SPECLT
- 2026FLUTICASONE PROPIONATEGeneric (ANDA)
ANDA 219602 · GLENMARK SPECLT
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.
