Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089990
Company: VINTAGE
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 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
09/30/1988 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-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/11/2008 SUPPL-6 Labeling

Label is not available on this site.

10/25/2007 SUPPL-5 Labeling

Label is not available on this site.

03/26/2007 SUPPL-4 Labeling

Label is not available on this site.

03/16/1995 SUPPL-2 Labeling

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;15MG
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 300MG;15MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 040419 MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 088627 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET;ORAL Prescription No AA 089990 VINTAGE

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