Drugs@FDA: FDA-Approved Drugs
Company: LANNETT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/29/1975 | 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 |
---|---|---|---|---|---|
10/13/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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02/25/2022 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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01/04/2017 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2015 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/08/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
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09/19/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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12/17/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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09/19/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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09/19/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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06/05/1987 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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01/17/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/03/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |