Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089828
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/11/2008 SUPPL-10 Labeling

Label is not available on this site.

10/18/2007 SUPPL-8 Labeling

Label is not available on this site.

01/10/2007 SUPPL-6 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;60MG
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;60MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 040419 MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 087083 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 088629 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 089828 VINTAGE PHARMS
TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

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