Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210859
Company: HETERO LABS LTD III

Products on ANDA 210859

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210859

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210859

EZETIMIBE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	211550	ACCORD HLTHCARE
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	209234	ALKEM LABS LTD
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	208803	AMNEAL PHARMS CO
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	209838	AUROBINDO PHARMA
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	078560	GLENMARK PHARMS LTD
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	210859	HETERO LABS LTD III
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	211159	MACLEODS PHARMS LTD
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	207311	OHM LABS INC
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	215693	ORIENT PHARMA
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	203931	SANDOZ
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	210673	SCIEGEN PHARMS INC
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	200831	WATSON LABS INC
EZETIMIBE	EZETIMIBE	10MG	TABLET;ORAL	Prescription	No	AB	204331	ZYDUS PHARMS
ZETIA	EZETIMIBE	10MG	TABLET;ORAL	Prescription	Yes	AB	021445	ORGANON