Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084051
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| DEXTROSTAT | DEXTROAMPHETAMINE SULFATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/29/1975 | 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 |
|---|---|---|---|---|---|
| 11/20/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/2002 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 02/28/2000 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 01/27/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/15/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/26/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/28/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/09/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |