Drugs@FDA: FDA-Approved Drugs
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/21/2010 | ORIG-3 | Approval |
Label is not available on this site. |
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07/22/2010 | ORIG-2 | Approval |
Label is not available on this site. |
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06/14/2010 | 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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-46 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/15/2023 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-43 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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03/04/2021 | SUPPL-42 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/11/2019 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/20/2018 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-32 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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05/26/2017 | SUPPL-29 | REMS-Modified |
Label is not available on this site. |
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09/28/2018 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/30/2016 | SUPPL-26 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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12/16/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2016 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
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06/26/2015 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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08/19/2014 | SUPPL-17 | REMS-Assessment |
Label is not available on this site. |
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04/16/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/15/2013 | SUPPL-6 | REMS-Proposal |
Label is not available on this site. |
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10/12/2012 | SUPPL-5 | REMS-Proposal |
Label is not available on this site. |
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10/12/2012 | SUPPL-4 | REMS-Proposal |
Label is not available on this site. |
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05/22/2012 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |