Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040482
Company: ANDA REPOSITORY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription AA 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
09/25/2003 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
10/28/2019 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-19 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/15/2018 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

10/18/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

03/30/2009 SUPPL-8 Labeling

Label is not available on this site.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

SOLUTION;ORAL; 325MG/15ML;7.5MG/15ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040482 ANDA REPOSITORY
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040894 GENUS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 040838 PHARM ASSOC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 200343 VISTAPHARM
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION;ORAL Prescription No AA 211023 WES PHARMA INC

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