# XULTOPHY 100/3.6
> **BLA208583** · Biologics License Application · Sponsor: NOVO · Approved 2016-11-21
## Drug
- **FDA Application Number:** BLA208583
- **Application type:** Biologics License Application
- **Brand name:** XULTOPHY 100/3.6
- **Generic name:** INSULIN DEGLUDEC AND LIRAGLUTIDE
- **Active ingredients:** INSULIN DEGLUDEC; LIRAGLUTIDE
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** NOVO
- **Manufacturer:** Novo Nordisk
- **First approval:** 2016-11-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208583)
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