# OSIMERTINIB MESYLATE
> **ANDA214263** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2021-06-01
## Drug
- **FDA Application Number:** ANDA214263
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OSIMERTINIB MESYLATE
- **Generic name:** Osimertinib Mesylate
- **Active ingredients:** OSIMERTINIB MESYLATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ZYDUS PHARMS USA INC
- **First approval:** 2021-06-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214263)
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