Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | 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 | 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 | 20MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | 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 |
---|---|---|---|---|---|---|---|
07/11/2013 | ORIG-2 | Approval |
Label is not available on this site. |
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12/13/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079046s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/15/2023 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/12/2023 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
03/04/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
10/10/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/10/2019 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/21/2018 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/18/2018 | SUPPL-28 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
05/26/2017 | SUPPL-27 | REMS-Modified |
Label is not available on this site. |
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12/16/2016 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
09/30/2016 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
12/16/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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04/20/2016 | SUPPL-23 | REMS-Modified |
Label is not available on this site. |
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06/26/2015 | SUPPL-21 | REMS-Modified |
Label is not available on this site. |
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08/19/2014 | SUPPL-18 | REMS-Modified |
Label is not available on this site. |
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04/17/2014 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/16/2014 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/079046Orig1s013lbl.pdf | |
11/21/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2013 | SUPPL-8 | REMS-Modified |
Label is not available on this site. |
||
07/09/2012 | SUPPL-4 | REMS-Proposal |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/16/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/079046Orig1s013lbl.pdf |