AEMCOLO (nda210910)- (EQ 194MG BASE)

Generic Name	RIFAMYCIN SODIUM	Innovator	REDHILL
Dosage	EQ 194MG BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2025-May-03	NCE Excl Expiry	2023-Nov-16
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	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
EQ 194MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of AEMCOLO