# TIGLUTIK KIT
> **NDA209080** · New Drug Application · Sponsor: ITALFARMACO SA · Approved 2018-09-05
## Drug
- **FDA Application Number:** NDA209080
- **Application type:** New Drug Application
- **Brand name:** TIGLUTIK KIT
- **Generic name:** RILUZOLE
- **Active ingredients:** RILUZOLE
- **Dosage form:** SUSPENSION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ITALFARMACO SA
- **Manufacturer:** EDW PHARMA, INC
- **First approval:** 2018-09-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209080)
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