Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210066
Company: HETERO LABS LTD V

Products on ANDA 210066

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APIXABAN	APIXABAN	2.5MG	TABLET;ORAL	Prescription	AB	No	No
APIXABAN	APIXABAN	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210066Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 210066

APIXABAN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APIXABAN	APIXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	210180	ACCORD HLTHCARE
APIXABAN	APIXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	210091	APOTEX
APIXABAN	APIXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	210066	HETERO LABS LTD V
APIXABAN	APIXABAN	2.5MG	TABLET;ORAL	Prescription	No	AB	209898	INDOCO
ELIQUIS	APIXABAN	2.5MG	TABLET;ORAL	Prescription	Yes	AB	202155	BRISTOL MYERS SQUIBB

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APIXABAN	APIXABAN	5MG	TABLET;ORAL	Prescription	No	AB	210180	ACCORD HLTHCARE
APIXABAN	APIXABAN	5MG	TABLET;ORAL	Prescription	No	AB	210091	APOTEX
APIXABAN	APIXABAN	5MG	TABLET;ORAL	Prescription	No	AB	210066	HETERO LABS LTD V
APIXABAN	APIXABAN	5MG	TABLET;ORAL	Prescription	No	AB	209898	INDOCO
ELIQUIS	APIXABAN	5MG	TABLET;ORAL	Prescription	Yes	AB	202155	BRISTOL MYERS SQUIBB