Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078828
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
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 |
---|---|---|---|---|---|---|---|
03/23/2009 | 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 |
---|---|---|---|---|---|
06/30/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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03/16/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |