Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/29/2009 | 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 |
---|---|---|---|---|---|
09/22/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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10/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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09/09/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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09/09/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/07/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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04/25/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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01/11/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |