Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091537
Company: DASH PHARMS
Company: DASH PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
RISPERIDONE | RISPERIDONE | 0.25MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
03/30/2011 | 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 |
---|---|---|---|---|---|
11/02/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/02/2023 | SUPPL-11 | Labeling-Patient Package Insert |
Label is not available on this site. |
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10/28/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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10/28/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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11/28/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/13/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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03/22/2013 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/12/2013 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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02/13/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |