NICORETTE (nda018612)- (EQ 2MG BASE,EQ 2MG BASE)

Generic Name	NICOTINE POLACRILEX	Innovator	HALEON US HOLDINGS
Dosage	EQ 2MG BASE,EQ 2MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Apr-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NICORETTE is indicated to reduce the withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	12

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
EQ 2MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	11

Manufacturing Details of NICORETTE