Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076440
Company: ANI PHARMS
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
01/30/2009 | 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 |
---|---|---|---|---|---|
07/14/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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07/14/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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07/14/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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09/27/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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01/11/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2009 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |