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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217968
Company: TEVA PHARMS USA INC

Products on ANDA 217968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAPATINIB DITOSYLATE	LAPATINIB DITOSYLATE	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217968

LAPATINIB DITOSYLATE

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LAPATINIB DITOSYLATE	LAPATINIB DITOSYLATE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	203007	NATCO PHARMA LTD
LAPATINIB DITOSYLATE	LAPATINIB DITOSYLATE	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	217968	TEVA PHARMS USA INC
TYKERB	LAPATINIB DITOSYLATE	EQ 250MG BASE	TABLET;ORAL	Prescription	Yes	AB	022059	NOVARTIS

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