An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 220374
Company: TORRENT

Products on ANDA 220374

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 220374

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220374

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
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	219559	APOTEX
FIDAXOMICIN	FIDAXOMICIN	200MG	TABLET;ORAL	Prescription	No	AB	220374	TORRENT

Top