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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210725
Company: APOTEX

Products on ANDA 210725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET;ORAL	Prescription	AB	No	No
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210725

AFATINIB DIMALEATE

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	210725	APOTEX
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	210750	HETERO LABS LTD V
GILOTRIF	AFATINIB DIMALEATE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	201292	BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	210725	APOTEX
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	210750	HETERO LABS LTD V
GILOTRIF	AFATINIB DIMALEATE	EQ 30MG BASE	TABLET;ORAL	Prescription	Yes	AB	201292	BOEHRINGER INGELHEIM

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	210725	APOTEX
AFATINIB DIMALEATE	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	210750	HETERO LABS LTD V
GILOTRIF	AFATINIB DIMALEATE	EQ 40MG BASE	TABLET;ORAL	Prescription	Yes	AB	201292	BOEHRINGER INGELHEIM

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