Advair Hfa
Fluticasone Propionate; Salmeterol Xinafoate
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Jun 08, 2006
20 yr 5 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Strength
0.115MG/INH;EQ 0.021MG BASE/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 021254
Product number
002
Marketing status
Prescription
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Other strengths in NDA 021254
Active-ingredient family
This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019Airduo DigihalerBrand (NDA)
NDA 208799 · Teva Pharm
- 2000Advair Diskus 100/50Brand (NDA)
NDA 021077 · Glaxo Grp Ltd
- 2026Fluticasone Propionate And Salmeterol XinafoateGeneric (ANDA)
ANDA 214464 · Respirent Pharms
- 2021Fluticasone Propionate And Salmeterol XinafoateGeneric (ANDA)
ANDA 213948 · Teva Pharms USA
- 2020Fluticasone Propionate And Salmeterol XinafoateGeneric (ANDA)
ANDA 203433 · Hikma
- 2019Wixela InhubGeneric (ANDA)
ANDA 208891 · Mylan
Listed 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.
Advair Hfa — 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 Propionate; Salmeterol Xinafoate 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.
