FdaApplication
NDA 205489
Identifiers
- fda_app_no: NDA205489
Properties
| Property | Value |
|---|---|
| applicant_name | NEOS THERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2017-06-19 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| COTEMPLA XR-ODT | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
| COTEMPLA XR-ODT | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
| COTEMPLA XR-ODT | METHYLPHENIDATE | 34.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
| COTEMPLA XR-ODT | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL |
4 products