FdaApplication
NDA 210526
Identifiers
- fda_app_no: NDA210526
Properties
| Property | Value |
|---|---|
| applicant_name | TRIS PHARMA INC |
| application_type | NDA |
| approval_date | 2021-11-04 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DYANAVEL XR 10 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 8MG;EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| DYANAVEL XR 15 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 12MG;EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| DYANAVEL XR 20 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 16MG;EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| DYANAVEL XR 5 | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 4MG;EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL |
4 products