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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212827
Company: NATCO

Products on ANDA 212827

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 212827

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212827

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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