# FOCALIN
> **NDA021278** · New Drug Application · Sponsor: SANDOZ · Approved 2001-11-13
## Drug
- **FDA Application Number:** NDA021278
- **Application type:** New Drug Application
- **Brand name:** FOCALIN
- **Generic name:** DEXMETHYLPHENIDATE HYDROCHLORIDE
- **Active ingredients:** DEXMETHYLPHENIDATE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** SANDOZ
- **Manufacturer:** Sandoz Inc
- **First approval:** 2001-11-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021278)
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*MORVS · CC0 1.0*