Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
07/15/2013 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/200822Orig1s000.Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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12/12/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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12/12/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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10/09/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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09/21/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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05/26/2017 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
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09/30/2016 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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03/10/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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03/10/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2016 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
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06/26/2015 | SUPPL-4 | REMS-Modified |
Label is not available on this site. |
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08/19/2014 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |
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04/16/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |