EMLA (nda019941)- (2.5%;2.5%)

Generic Name	LIDOCAINE; PRILOCAINE	Innovator	TEVA BRANDED PHARM
Dosage	2.5%;2.5%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2002-Dec-31	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	EMLA Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	6

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5%;2.5%	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of EMLA