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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202946
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
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
06/27/2014 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
03/04/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-8 REMS - MODIFIED - D-N-A

Label is not available on this site.

05/26/2017 SUPPL-7 REMS-Modified

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/30/2016 SUPPL-5 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/20/2016 SUPPL-3 REMS-Modified

Label is not available on this site.

06/26/2015 SUPPL-2 REMS-Proposal

Label is not available on this site.

08/19/2014 SUPPL-1 REMS-Modified

Label is not available on this site.

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