# ONTRALFY
> **NDA216190** · New Drug Application · Sponsor: FIDELITY BIOPHARMA · Approved 2024-12-12
## Drug
- **FDA Application Number:** NDA216190
- **Application type:** New Drug Application
- **Brand name:** ONTRALFY
- **Generic name:** TIZANIDINE HYDROCHLORIDE
- **Active ingredients:** TIZANIDINE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** FIDELITY BIOPHARMA
- **Manufacturer:** Rosemont Pharmaceuticals, LLC
- **First approval:** 2024-12-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216190)
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