Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087508
Company: PHARM ASSOC
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/21/1981 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-39 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/01/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

08/25/2008 SUPPL-31 Labeling

Label is not available on this site.

03/07/2008 SUPPL-30 Labeling

Label is not available on this site.

07/19/1994 SUPPL-24 Labeling

Label is not available on this site.

08/17/1993 SUPPL-23 Labeling

Label is not available on this site.

12/02/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/18/1991 SUPPL-21 Labeling

Label is not available on this site.

08/08/1991 SUPPL-20 Labeling

Label is not available on this site.

05/09/1991 SUPPL-19 Labeling

Label is not available on this site.

12/28/1989 SUPPL-18 Labeling

Label is not available on this site.

12/18/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/18/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-13 Labeling

Label is not available on this site.

06/09/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/18/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/18/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/16/1982 SUPPL-2 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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