Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085883
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPITAL AND CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SUSPENSION;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
01/08/1979 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
12/16/2016 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/04/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

09/07/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2000 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/07/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/15/1996 SUPPL-23 Labeling

Label is not available on this site.

09/22/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-21 Labeling

Label is not available on this site.

10/08/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/21/1990 SUPPL-17 Labeling

Label is not available on this site.

11/02/1989 SUPPL-16 Labeling

Label is not available on this site.

11/02/1989 SUPPL-11 Labeling

Label is not available on this site.

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