# IRESSA
> **NDA021399** · New Drug Application · Sponsor: ASTRAZENECA · Approved 2003-05-05
## Drug
- **FDA Application Number:** NDA021399
- **Application type:** New Drug Application
- **Brand name:** IRESSA
- **Generic name:** Gefitinib
- **Active ingredients:** GEFITINIB
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** ASTRAZENECA
- **First approval:** 2003-05-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021399)
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