Orange Book product · Generic (ANDA)
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
At a glance
Jan 12, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
ANDA 214464
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
- 2019AIRDUO DIGIHALERBrand (NDA)
NDA 208799 · TEVA PHARM
- 2006ADVAIR HFABrand (NDA)
NDA 021254 · GLAXO GRP LTD
- 2000ADVAIR DISKUS 100/50Brand (NDA)
NDA 021077 · GLAXO GRP LTD
- 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.
