FdaApplication
ANDA 204330
Identifiers
- fda_app_no: ANDA204330
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2016-03-16 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL |
2 products