ORAQIX (nda021451)- (2.5%;2.5%)

Generic Name	LIDOCAINE; PRILOCAINE	Innovator	DENTSPLY PHARM
Dosage	2.5%;2.5%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2017-Apr-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.

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
2.5%;2.5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ORAQIX