ADVAIR HFA (nda021254)- (0.045MG/INH;EQ 0.021MG BASE/INH,0.115MG/INH;EQ 0.021MG BASE/INH,0.23MG/INH;EQ 0.021MG BASE/INH)

Generic Name	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	Innovator	GLAXO GRP LTD
Dosage	0.045MG/INH;EQ 0.021MG BASE/INH,0.115MG/INH;EQ 0.021MG BASE/INH,0.23MG/INH;EQ 0.021MG BASE/INH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2026-Aug-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ADVAIR HFA is indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.045MG/INH;EQ 0.021MG BASE/INH	**	**	Down	-	-
0.115MG/INH;EQ 0.021MG BASE/INH	**	**	Down	-	-
0.23MG/INH;EQ 0.021MG BASE/INH	**	**	Down	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ADVAIR HFA