Details for New Drug Application (NDA): 208443

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NDA 208443 describes FIDAXOMICIN, which is a drug marketed by Actavis Labs Fl and is included in one NDA. Additional details are available on the FIDAXOMICIN profile page.

The generic ingredient in FIDAXOMICIN is fidaxomicin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.

Summary for 208443

Tradename:	FIDAXOMICIN
Applicant:	Actavis Labs Fl
Ingredient:	fidaxomicin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 16, 2024	TE:		RLD:	No

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