XYLOCAINE (nda006488)- (0.5%,1%,1.5%,2%)

Generic Name	LIDOCAINE HYDROCHLORIDE	Innovator	FRESENIUS KABI USA
Dosage	0.5%,1%,1.5%,2%
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	Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
27	0	25

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
0.5%	**	**	-	-	-
1%	**	**	-	1	9
1.5%	**	**	-	-	-
2%	**	**	-	3	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	21

Manufacturing Details of XYLOCAINE