Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083902
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ELIXIR;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/26/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/14/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |