OMIDRIA (nda205388)- (EQ 0.3% BASE;EQ 1% BASE)

Generic Name	KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE	Innovator	RAYNER SURGICAL
Dosage	EQ 0.3% BASE;EQ 1% BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2034-Apr-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2017-May-30
GAIN Expiry	None	Drug Complexity	No
Indication	OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for:  Maintaining pupil size by preventing intraoperative miosis  Reducing postoperative pain.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	1	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
EQ 0.3% BASE;EQ 1% BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OMIDRIA