# TAGRISSO
> **NDA208065** · New Drug Application · Sponsor: ASTRAZENECA · Approved 2015-11-13
## Drug
- **FDA Application Number:** NDA208065
- **Application type:** New Drug Application
- **Brand name:** TAGRISSO
- **Generic name:** OSIMERTINIB
- **Active ingredients:** OSIMERTINIB MESYLATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ASTRAZENECA
- **Manufacturer:** AstraZeneca Pharmaceuticals LP
- **First approval:** 2015-11-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065)
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