ACCUNEB (nda020949)- (EQ 0.042% BASE,EQ 0.021% BASE)

Generic Name	ALBUTEROL SULFATE	Innovator	NORVIUM BIOSCIENCE
Dosage	EQ 0.042% BASE,EQ 0.021% BASE
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	AccuNeb is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.042% BASE	**	**	-	3	-
EQ 0.021% BASE	**	**	-	2	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of ACCUNEB