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  1. Development & Approval Process (Drugs)

Additions/Deletions for Prescription and OTC Drug Product Lists

Additions/Deletions for Prescription and OTC Drug Product Lists

Orange Book Home Page

This document is not a cumulative list of approved Prescription and OTC Drug Products but a list of the new additions and new deletions to the Prescription and OTC Drug Product Lists for a specific month. This information must be used in conjunction with the most current Cumulative Supplement and Orange Book. Additions and deletions are identified in this document by the symbols >ADD> and >DLT>, respectively. Products that have never been marketed, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" symbol in the 12th Cumulative Supplement of the current Edition List will then be added to the "Discontinued Drug Product List" of the following Edition. 

  • >ADD> or >A>  indicates Addition
  • >DLT> or >D> indicates Deletion
  • @ indicates drugs that have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons

2019 Additions and Deletions to Drug Product List

2018 Additions and Deletions to Drug Product List

2017 Additions and Deletions to Drug Product List

2016 Additions and Deletions to Drug Product List

2015 Additions and Deletions to Drug Product List

2014 Additions and Deletions to Drug Product List

2013 Additions and Deletions to Drug Product List

2012 Additions and Deletions to Drug Product List

2011 Additions and Deletions to Drug Product List

2010 Additions and Deletions to Drug Product List

2009 Additions and Deletions to Drug Product List

2008 Additions and Deletions to Drug Product List