QLOSI (NDA217836)- (0.4%)

Generic Name	PILOCARPINE HYDROCHLORIDE	Innovator	ORASIS PHARMS
Dosage	0.4%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2037-Aug-18	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2026-Oct-17
GAIN Expiry	None	Drug Complexity	No
Indication	QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
0.4%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of QLOSI