KETALAR (nda016812)- (EQ 10MG BASE/ML,EQ 50MG BASE/ML,EQ 100MG BASE/ML)

Generic Name	KETAMINE HYDROCHLORIDE	Innovator	ENDO OPERATIONS
Dosage	EQ 10MG BASE/ML,EQ 50MG BASE/ML,EQ 100MG BASE/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	KETALAR is a general anesthetic indicated: • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation • for the induction of anesthesia prior to the administration of other general anesthetic agents • as a supplement to other anesthetic agents

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 10MG BASE/ML	**	**	-	-	-
EQ 50MG BASE/ML	**	**	-	-	-
EQ 100MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of KETALAR