CLOROTEKAL (nda208791)- (50MG/5ML (10MG/ML))

Generic Name	CHLOROPROCAINE HYDROCHLORIDE	Innovator	B BRAUN MEDICAL INC
Dosage	50MG/5ML (10MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2033-Dec-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2020-Sep-26
GAIN Expiry	None	Drug Complexity	No
Indication	CLOROTEKAL® is an ester local anesthetic indicated for intrathecal injection in adults for the production of subarachnoid block (spinal anesthesia).

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
50MG/5ML (10MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CLOROTEKAL