ASMANEX TWISTHALER (nda021067)- (0.11MG/INH,0.22MG/INH)

Generic Name	MOMETASONE FUROATE	Innovator	ORGANON LLC
Dosage	0.11MG/INH,0.22MG/INH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2018-Sep-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ASMANEX TWISTHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.11MG/INH	**	**	Up	-	-
0.22MG/INH	**	**	Down	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ASMANEX TWISTHALER