XHANCE (nda209022)- (0.093MG)

Generic Name	FLUTICASONE PROPIONATE	Innovator	OPTINOSE US INC
Dosage	0.093MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2036-Feb-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2020-Sep-18
GAIN Expiry	None	Drug Complexity	No
Indication	XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.093MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of XHANCE