LOTEMAX SM (nda208219)- (0.38%)

Generic Name	LOTEPREDNOL ETABONATE	Innovator	BAUSCH AND LOMB INC
Dosage	0.38%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2036-Dec-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LOTEMAX® SM is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.38%	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LOTEMAX SM