FdaApplication
NDA 022063
Identifiers
- fda_app_no: NDA022063
Properties
| Property | Value |
|---|---|
| applicant_name | TAKEDA PHARMACEUTICALS USA INC |
| application_type | NDA |
| approval_date | 2017-06-20 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL |
4 products