Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090415
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;10MG TABLET;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
01/24/2011 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-23 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/11/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-16 REMS - PROPOSAL - D-N-A

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-9 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/23/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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