Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077953
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Discontinued | None | No | No |
| RISPERIDONE | RISPERIDONE | 4MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/2008 | 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 |
|---|---|---|---|---|---|
| 09/11/2025 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/28/2020 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/28/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/23/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/05/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/27/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |