Orange Book product · Brand (NDA)
ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
At a glance
Aug 24, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 24, 2000
26 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
AB
Application
NDA 021077
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.
- 2019AIRDUO DIGIHALERBrand (NDA)
NDA 208799 · TEVA PHARM
- 2006ADVAIR HFABrand (NDA)
NDA 021254 · 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.
