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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200822
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.
12/12/2023 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
12/12/2023 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
10/09/2019 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-12 REMS - MODIFIED - D-N-A

Label is not available on this site.
05/26/2017 SUPPL-11 REMS-Modified

Label is not available on this site.
09/30/2016 SUPPL-10 REMS - MODIFIED - D-N-A

Label is not available on this site.
03/10/2017 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
03/10/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
04/20/2016 SUPPL-6 REMS-Modified

Label is not available on this site.
06/26/2015 SUPPL-4 REMS-Modified

Label is not available on this site.
08/19/2014 SUPPL-3 REMS-Modified

Label is not available on this site.
04/16/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.
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