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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021399
Company: ASTRAZENECA

Products on NDA 021399

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IRESSA	GEFITINIB	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021399

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021399lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-399_IRESSA_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021399_iressa.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2005	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021399s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021399s008ltr.pdf
11/19/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399s005ltr.pdf
05/06/2004	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21399slr003_Iressa_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399slr003ltr.pdf

Labels for NDA 021399

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2005	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021399s008lbl.pdf
05/06/2004	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21399slr003_Iressa_lbl.pdf
05/05/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021399lbl.pdf

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