FdaApplication
NDA 021475
Identifiers
- fda_app_no: NDA021475
Properties
| Property | Value |
|---|---|
| applicant_name | SPECGX LLC |
| application_type | NDA |
| approval_date | 2003-04-15 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
| METHYLIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE;ORAL |
3 products