Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089997
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG 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
08/29/2017 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/31/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

11/17/2000 SUPPL-9 Labeling

Label is not available on this site.

11/17/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/17/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/17/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/2000 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/21/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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