Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040881
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG/15ML;10MG/15ML SOLUTION;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
02/25/2010 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
10/11/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-10 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/24/2018 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

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

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/15/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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