ACUVAIL (nda022427)- (0.45%)

Generic Name	KETOROLAC TROMETHAMINE	Innovator	ABBVIE
Dosage	0.45%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Aug-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2012-Jul-22
GAIN Expiry	None	Drug Complexity	No
Indication	ACUVAIL® ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for the treatment of pain and inflammation following cataract surgery.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.45%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ACUVAIL