# GILENYA
> **NDA022527** · New Drug Application · Sponsor: NOVARTIS · Approved 2010-09-21
## Drug
- **FDA Application Number:** NDA022527
- **Application type:** New Drug Application
- **Brand name:** GILENYA
- **Generic name:** FINGOLIMOD HCL
- **Active ingredients:** FINGOLIMOD HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVARTIS
- **Manufacturer:** Novartis Pharmaceuticals Corporation
- **First approval:** 2010-09-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022527)
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