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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206995
Company: ASTRAZENECA

Products on NDA 206995

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRESSA	GEFITINIB	250MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206995

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206995Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206995Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206995Orig1s004ltr.pdf
08/22/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206995s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206995Orig1s003Ltr.pdf

Labels for NDA 206995

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf
08/22/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206995s003lbl.pdf
07/13/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206995s000lbl.pdf

Therapeutic Equivalents for NDA 206995

IRESSA

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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