ALLI (nda021887)- (60MG)

Generic Name	ORLISTAT	Innovator	HALEON US HOLDINGS
Dosage	60MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Jan-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ALLI is indicated for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	24

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
60MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ALLI