Application 084051
- Type
- ANDA
- Sponsor
- SHIRE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44405 | ORIG | 2011-12-20 |