IMODIUM MULTI-SYMPTOM RELIEF (nda020606)- (2MG;125MG)

Generic Name	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	Innovator	J AND J CONSUMER INC
Dosage	2MG;125MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2014-Oct-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	IMODIUM MULTI-SYMPTOM RELIEF is indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	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
2MG;125MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of IMODIUM MULTI-SYMPTOM RELIEF