DUONEB (nda020950)- (EQ 0.083% BASE;0.017%)

Generic Name	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	Innovator	NORVIUM BIOSCIENCE
Dosage	EQ 0.083% BASE;0.017%
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2021-Dec-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DuoNeb is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	4

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.083% BASE;0.017%	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of DUONEB