Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040680
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG/5ML;5MG/5ML SOLUTION;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
09/29/2006 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
10/08/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-11 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/21/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

05/23/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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