TEPYLUTE (NDA216984)- (15MG/1.5ML (10MG/ML))

Generic Name	THIOTEPA	Innovator	SHORLA
Dosage	15MG/1.5ML (10MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2041-Aug-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary.

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
15MG/1.5ML (10MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TEPYLUTE