Orange Book product · Brand (NDA)
ARNUITY ELLIPTA
FLUTICASONE FUROATE
At a glance
May 17, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 17, 2018
8 yr 3 mo ago
Exclusivity ends · M-290
New use / labeling-change exclusivity (3 years)
Mar 01, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUTICASONE FUROATE
Strength
0.05MG/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 205625
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Marketing exclusivity (1)
- M-290New use / labeling-change exclusivity (3 years)
Mar 01, 2026
4 mo ago
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.
