Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078036
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS 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 |
|---|---|---|---|---|---|---|---|
| 03/10/2014 | ORIG-1 | Approval |
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