NILSTAT (nda050299)- (100,000 UNITS/ML)

Generic Name	NYSTATIN	Innovator	CHARTWELL MOLECULES
Dosage	100,000 UNITS/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NILSTAT oral suspension is indicated for treatment of candidiasis in the oral cavity.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
9	0	7

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
100,000 UNITS/ML	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	7

Manufacturing Details of NILSTAT