Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087083
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;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
01/23/1980 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-49 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-48 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

03/20/2014 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

05/14/2013 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/23/2011 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

06/05/2008 SUPPL-42 Labeling

Label is not available on this site.

10/18/2007 SUPPL-41 Labeling

Label is not available on this site.

09/03/2002 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

09/03/2002 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/2002 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

01/05/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/09/1995 SUPPL-28 Labeling

Label is not available on this site.

01/09/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

01/09/1995 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/29/1989 SUPPL-25 Labeling

Label is not available on this site.

08/25/1988 SUPPL-24 Labeling

Label is not available on this site.

02/06/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/06/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/21/1986 SUPPL-13 Manufacturing (CMC)

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English