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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021399

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NDA 021399 describes IRESSA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.

Summary for 021399

Tradename:	IRESSA
Applicant:	Astrazeneca
Ingredient:	gefitinib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 5, 2003	TE:		RLD:	No

Expired US Patents for NDA 021399

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	021399-001	May 5, 2003	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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