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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089450
Company: CHARTWELL

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 Prescription AA 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
10/27/1992 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
12/15/2023 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/15/2023 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
03/05/2021 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/07/2019 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-24 REMS - PROPOSAL - D-N-A

Label is not available on this site.
02/21/2018 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
08/25/2017 SUPPL-22 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/29/2017 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/18/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
05/14/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
06/28/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
11/16/2007 SUPPL-13 Labeling

Label is not available on this site.
09/12/2007 SUPPL-12 Labeling

Label is not available on this site.
08/13/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
07/31/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/31/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
12/08/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/08/1997 SUPPL-5 Labeling

Label is not available on this site.
04/08/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
02/12/1996 SUPPL-2 Labeling

Label is not available on this site.
09/01/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

SOLUTION;ORAL; 120MG/5ML;12MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 089450 CHARTWELL
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 087508 GENUS LIFESCIENCES
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