Drugs@FDA: FDA-Approved Drugs
Company: HERITAGE PHARMA AVET
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 |
---|---|---|---|---|---|---|---|
06/30/2008 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076228s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/04/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2012 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
11/10/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
06/20/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
03/15/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
12/29/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
05/26/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/26/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/23/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/19/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/30/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076228s000lbl.pdf |