ORABLOC (nda022466)- (4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML),4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML))

Generic Name	ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	Innovator	PIERREL
Dosage	4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML),4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ORABLOC is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older.

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
4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)	**	**	-	-	-
4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ORABLOC