Iressa

NDA 21399, held by Astrazeneca. Gefitinib.

As of Nov 14, 2026, NDA 21399 (Iressa), held by Astrazeneca, was first approved by FDA on May 5, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: May 5, 2003
Review: Priority
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 5, 2003	Original applicationNew molecular entity · Priority review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Iressa250MG · tablet;oral	Gefitinib	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 17, 2005	Supplement 8Labeling · Priority review	Approved	Letter Label
Nov 19, 2004	Supplement 5Labeling · Priority review	Approved	Letter
May 6, 2004	Supplement 3Labeling · Priority review	Approved	Label Letter
May 5, 2003	Original applicationNew molecular entity · Priority review	Approved	Letter Review Label

Identifiers

Application: NDA 21399
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters