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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089999
Company: CHARTWELL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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
12/28/1994 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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/09/2019 SUPPL-22 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Label is not available on this site.

09/18/2018 SUPPL-20 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/29/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/30/2000 SUPPL-8 Labeling

Label is not available on this site.

11/30/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/30/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/30/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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