Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078071
Company: AMNEAL
Company: AMNEAL
| 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 |
|---|---|---|---|---|---|---|---|
| 06/17/2009 | 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 |
|---|---|---|---|---|---|
| 08/13/2025 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/13/2025 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 11/28/2011 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |