Drugs@FDA: FDA Approved Drug Products

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