Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084935
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 08/17/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/23/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 11/28/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/24/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/27/1999 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/30/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/22/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/22/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |