MITOSOL (nda022572)- (0.2MG/VIAL)

Generic Name	MITOMYCIN	Innovator	MOBIUS THERAP
Dosage	0.2MG/VIAL
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2029-May-21	NCE Excl Expiry	Expired
ODE Expiry	2019-Feb-07	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Mitosol® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

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
0.2MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of MITOSOL