# TRESIBA
> **BLA203314** · Biologics License Application · Sponsor: NOVO · Approved 2015-09-25
## Drug
- **FDA Application Number:** BLA203314
- **Application type:** Biologics License Application
- **Brand name:** TRESIBA
- **Generic name:** INSULIN DEGLUDEC
- **Active ingredients:** INSULIN DEGLUDEC
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** NOVO
- **Manufacturer:** Novo Nordisk
- **First approval:** 2015-09-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203314)
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