# ROZLYTREK
> **NDA212725** · New Drug Application · Sponsor: GENENTECH INC · Approved 2019-08-15
## Drug
- **FDA Application Number:** NDA212725
- **Application type:** New Drug Application
- **Brand name:** ROZLYTREK
- **Generic name:** ENTRECTINIB
- **Active ingredients:** ENTRECTINIB
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** GENENTECH INC
- **Manufacturer:** Genentech, Inc.
- **First approval:** 2019-08-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212725)
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