Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087006
Company: WOCKHARDT
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
07/22/1981 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-31 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-30 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/20/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

07/30/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/12/2007 SUPPL-25 Labeling

Label is not available on this site.

09/21/2007 SUPPL-24 Labeling

Label is not available on this site.

05/17/2005 SUPPL-23 Labeling

Label is not available on this site.

02/09/1998 SUPPL-21 Labeling

Label is not available on this site.

12/20/1993 SUPPL-20 Labeling

Label is not available on this site.

03/03/1992 SUPPL-19 Labeling

Label is not available on this site.

09/03/1991 SUPPL-18 Labeling

Label is not available on this site.

09/15/1989 SUPPL-17 Labeling

Label is not available on this site.

04/27/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/10/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/24/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/16/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-3 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 040119 HI TECH PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 089450 MIKART
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 087508 PHARM ASSOC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 091238 VINTAGE PHARMS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;ORAL Prescription No AA 087006 WOCKHARDT

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