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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091238
Company: CHARTWELL MOLECULAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/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
11/10/2011 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-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-15 REMS - PROPOSAL - D-N-A

Label is not available on this site.

02/21/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/21/2018 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/29/2017 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Label is not available on this site.

12/16/2016 SUPPL-9 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.

10/18/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/27/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/27/2013 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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