TUDORZA PRESSAIR (nda202450)- (0.4MG/INH)

Generic Name	ACLIDINIUM BROMIDE	Innovator	COVIS
Dosage	0.4MG/INH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2029-Mar-13	NCE Excl Expiry	2017-Jul-23
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

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
0.4MG/INH	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TUDORZA PRESSAIR