# MYSOLINE
> **NDA009170** · New Drug Application · Sponsor: VALEANT · Approved 1954-03-08
## Drug
- **FDA Application Number:** NDA009170
- **Application type:** New Drug Application
- **Brand name:** MYSOLINE
- **Generic name:** PRIMIDONE
- **Active ingredients:** PRIMIDONE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** VALEANT
- **Manufacturer:** Bausch Health US, LLC
- **First approval:** 1954-03-08
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009170)
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