Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040608
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;2.5MG TABLET;ORAL Prescription None No Yes
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;5MG TABLET;ORAL Prescription None No Yes
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;7.5MG TABLET;ORAL Prescription None No Yes
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG;10MG TABLET;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
12/30/2005 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-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-13 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/24/2018 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/01/2011 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/25/2007 SUPPL-1 Labeling

Label is not available on this site.

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