Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040419
Company: MALLINCKRODT INC
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 Yes
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription AA No No
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
05/31/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40419ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2016 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/18/2013 SUPPL-16 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-12 Labeling-Package Insert

Label is not available on this site.

02/21/2008 SUPPL-11 Labeling

Label is not available on this site.

11/30/2007 SUPPL-10 Labeling

Label is not available on this site.

12/13/2002 SUPPL-4 Labeling

Label is not available on this site.

12/13/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/13/2002 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2002 SUPPL-1 Manufacturing (CMC)-Facility

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

TABLET;ORAL; 300MG;30MG
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;30MG TABLET;ORAL Prescription No AA 040779 AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040419 MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085868 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 088628 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 089805 VINTAGE
TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

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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