FdaApplication
ANDA 084051
Identifiers
- fda_app_no: ANDA084051
Properties
| Property | Value |
|---|---|
| applicant_name | SHIRE DEVELOPMENT INC |
| application_type | ANDA |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products