Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089990
Company: VINTAGE
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/30/1988 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
03/04/2021 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-26 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-15 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-8 Labeling-Package Insert

Label is not available on this site.

02/11/2008 SUPPL-6 Labeling

Label is not available on this site.

10/25/2007 SUPPL-5 Labeling

Label is not available on this site.

03/26/2007 SUPPL-4 Labeling

Label is not available on this site.

03/16/1995 SUPPL-2 Labeling

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