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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079046
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.
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-Medication Guide, Labeling-Package Insert

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-Medication Guide, Labeling-Package Insert

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-Medication Guide, Labeling-Package Insert

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.
12/16/2016 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

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.
04/20/2016 SUPPL-23 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-21 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-18 REMS-Modified

Label is not available on this site.
04/17/2014 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
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
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