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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208443
Company: ACTAVIS LABS FL

Products on ANDA 208443

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208443

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208443Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208443

FIDAXOMICIN

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIFICID	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	Yes	AB	201699	CUBIST PHARMS LLC
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	208443	ACTAVIS LABS FL

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