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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209532
Company: APOTEX

Products on ANDA 209532

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209532

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209532Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209532

GEFITINIB

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GEFITINIB	GEFITINIB	250MG	TABLET;ORAL	Prescription	No	AB	208913	ACTAVIS LABS FL INC
GEFITINIB	GEFITINIB	250MG	TABLET;ORAL	Prescription	No	AB	209532	APOTEX
GEFITINIB	GEFITINIB	250MG	TABLET;ORAL	Prescription	No	AB	212827	NATCO
GEFITINIB	GEFITINIB	250MG	TABLET;ORAL	Prescription	No	AB	211591	QILU PHARM HAINAN
IRESSA	GEFITINIB	250MG	TABLET;ORAL	Prescription	Yes	AB	206995	ASTRAZENECA

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