Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085652
Company: LANNETT
Company: LANNETT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1980 | 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-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/25/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/10/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |