# ROZLYTREK
> **NDA218550** · New Drug Application · Sponsor: GENENTECH INC · Approved 2023-10-20
## Drug
- **FDA Application Number:** NDA218550
- **Application type:** New Drug Application
- **Brand name:** ROZLYTREK
- **Generic name:** ENTRECTINIB
- **Active ingredients:** ENTRECTINIB
- **Dosage form:** PELLETS
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GENENTECH INC
- **Manufacturer:** Genentech, Inc.
- **First approval:** 2023-10-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218550)
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