FdaApplication
NDA 209905
Identifiers
- fda_app_no: NDA209905
Properties
| Property | Value |
|---|---|
| applicant_name | AZURITY PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2019-01-30 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EVEKEO ODT | AMPHETAMINE SULFATE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| EVEKEO ODT | AMPHETAMINE SULFATE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| EVEKEO ODT | AMPHETAMINE SULFATE | 5MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| EVEKEO ODT | AMPHETAMINE SULFATE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL |
| EVEKEO ODT | AMPHETAMINE SULFATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
5 products