Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077719
Company: PHARM ASSOC
Company: PHARM ASSOC
| 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 |
|---|---|---|---|---|---|
| 12/27/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2022 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/27/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2012 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |