IMODIUM A-D (nda019487)- (1MG/5ML)

Generic Name	LOPERAMIDE HYDROCHLORIDE	Innovator	KENVUE BRANDS
Dosage	1MG/5ML
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	IMODIUM A-D EZ CHEWS is indicated to control symptoms of diarrhea, including Travelers' Diarrhea.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1MG/5ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of IMODIUM A-D