Application 083902
- Type
- ANDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXEDRINE | DEXTROAMPHETAMINE SULFATE | ELIXIR;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44404 | ORIG | 2007-05-18 |