NIMBEX PRESERVATIVE FREE (nda020551)- (EQ 10MG BASE/ML,EQ 2MG BASE/ML)

Generic Name	CISATRACURIUM BESYLATE	Innovator	ABBVIE
Dosage	EQ 10MG BASE/ML,EQ 2MG BASE/ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2012-Sep-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NIMBEX is a nondepolarizing neuromuscular blocker indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance • for mechanical ventilation in the ICU in adults

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
13	0	12

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
EQ 10MG BASE/ML	**	**	-	-	-
EQ 2MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	5

Manufacturing Details of NIMBEX PRESERVATIVE FREE