Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085861
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;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
06/20/1978 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-74 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-73 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-72 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/14/2017 SUPPL-71 Labeling-Package Insert

Label is not available on this site.

11/04/2015 SUPPL-70 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-69 Labeling-Package Insert

Label is not available on this site.

06/27/2008 SUPPL-68 Labeling

Label is not available on this site.

04/02/2001 SUPPL-47 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/2000 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/24/1994 SUPPL-43 Labeling

Label is not available on this site.

09/22/1994 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-41 Labeling

Label is not available on this site.

07/16/1993 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/16/1993 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/29/1993 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/03/1991 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/08/1990 SUPPL-33 Labeling

Label is not available on this site.

04/06/1992 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/08/1990 SUPPL-29 Labeling

Label is not available on this site.

05/18/1990 SUPPL-28 Labeling

Label is not available on this site.

05/18/1990 SUPPL-26 Labeling

Label is not available on this site.

03/16/1989 SUPPL-25 Labeling

Label is not available on this site.

09/14/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/14/1990 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/08/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/11/1988 SUPPL-19 Labeling

Label is not available on this site.

05/18/1990 SUPPL-18 Labeling

Label is not available on this site.

12/19/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/23/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/05/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/26/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/21/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/03/1982 SUPPL-12 Manufacturing (CMC)

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