Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040223
Company: DURAMED PHARMS BARR
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 Discontinued None No No
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Discontinued None No No
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Discontinued None 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
11/18/1997 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
10/21/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

10/21/2013 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

02/14/2008 SUPPL-23 Labeling

Label is not available on this site.

10/25/2007 SUPPL-22 Labeling

Label is not available on this site.

12/09/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2002 SUPPL-13 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/09/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

04/09/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

04/09/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

04/09/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

06/05/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/05/2000 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/05/2000 SUPPL-5 Labeling

Label is not available on this site.

06/05/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2000 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/05/2000 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/20/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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