FdaApplication
NDA 021278
Identifiers
- fda_app_no: NDA021278
Properties
| Property | Value |
|---|---|
| applicant_name | SANDOZ INC |
| application_type | NDA |
| approval_date | 2001-11-13 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL |
3 products