Arnuity Ellipta
Fluticasone Furoate
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2014
12 yr 1 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
FLUTICASONE FUROATE
Strength
0.1MG/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 205625
Product number
001
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Other strengths in NDA 205625
Active-ingredient family
This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
View full Fluticasone Furoate familyListed patents
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.
Arnuity Ellipta — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Fluticasone Furoate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
