OCUFEN (nda019404)- (0.03%)

Generic Name	FLURBIPROFEN SODIUM	Innovator	ALLERGAN
Dosage	0.03%
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	OCUFEN® ophthalmic solution is indicated for the inhibition of intraoperative miosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	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
0.03%	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of OCUFEN