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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079087
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.
07/22/2010 ORIG-2 Approval

Label is not available on this site.
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-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-45 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-44 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-43 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-42 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.
10/11/2019 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/20/2018 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-32 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-29 REMS-Modified

Label is not available on this site.
09/28/2018 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/30/2016 SUPPL-26 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.
12/15/2016 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
04/20/2016 SUPPL-20 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-18 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-17 REMS-Assessment

Label is not available on this site.
04/16/2014 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/15/2013 SUPPL-6 REMS-Proposal

Label is not available on this site.
10/12/2012 SUPPL-5 REMS-Proposal

Label is not available on this site.
10/12/2012 SUPPL-4 REMS-Proposal

Label is not available on this site.
05/22/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.
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