ACULAR LS (nda021528)- (0.4%)

Generic Name	KETOROLAC TROMETHAMINE	Innovator	ABBVIE
Dosage	0.4%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2027-Nov-24	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ACULAR LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	0

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
0.4%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ACULAR LS