RETIN-A-MICRO (nda020475)- (0.06%,0.08%)

Generic Name	TRETINOIN	Innovator	BAUSCH
Dosage	0.06%,0.08%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2016-Sep-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Retin-A Micro (tretinoin) Gel microsphere, 0.1%, 0.08% and 0.04%, is a retinoid, indicated for topical treatment of acne vulgaris.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.06%	**	**	-	-	-
0.08%	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of RETIN-A-MICRO