Orange Book product · Brand (NDA)
ADVAIR HFA
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
At a glance
Jun 08, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 08, 2006
20 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Strength
0.045MG/INH;EQ 0.021MG BASE/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 021254
Product number
001
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.
- 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
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.
