Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085868
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG 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
11/06/1978 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-62 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/29/2017 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-60 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-59 Labeling-Package Insert

Label is not available on this site.

03/20/2014 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

05/14/2013 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-56 Labeling-Package Insert

Label is not available on this site.

06/05/2008 SUPPL-55 Labeling

Label is not available on this site.

10/18/2007 SUPPL-54 Labeling

Label is not available on this site.

09/05/2002 SUPPL-48 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2002 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-44 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-43 Manufacturing (CMC)-Facility

Label is not available on this site.

01/09/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/09/1995 SUPPL-41 Labeling

Label is not available on this site.

01/09/1995 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

01/09/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/12/1989 SUPPL-38 Labeling

Label is not available on this site.

08/25/1988 SUPPL-37 Labeling

Label is not available on this site.

02/06/1987 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/15/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/13/1982 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/14/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/14/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

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

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