ERYGEL (nda050617)- (2%)

Generic Name	ERYTHROMYCIN	Innovator	MYLAN
Dosage	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	ERYGEL® Topical Gel is indicated for the topical treatment of acne vulgaris.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	1

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%	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of ERYGEL