# ONIVYDE
> **NDA207793** · New Drug Application · Sponsor: IPSEN · Approved 2015-10-22
## Drug
- **FDA Application Number:** NDA207793
- **Application type:** New Drug Application
- **Brand name:** ONIVYDE
- **Generic name:** IRINOTECAN HYDROCHLORIDE
- **Active ingredients:** IRINOTECAN HYDROCHLORIDE
- **Dosage form:** INJECTABLE, LIPOSOMAL
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** IPSEN
- **Manufacturer:** Ipsen Biopharmaceuticals, Inc.
- **First approval:** 2015-10-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207793)
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