2005P-0096
Volume 1
CP 1

Citizen Petition

Exhibit 1 - Claritin Marketing History

Exhibit 2 - FDA Review of Claritin for OTC

Exhibit 3 - FDA Approves OTC Claritin; Claritin Syrup, Claritin Hives Relief Syrup, and Tablet dosage forms - application and approval dates

Exhibit 4 - Claritin Hives Relief (Overview - Drugs@FDA)

Exhibit 5 - Claritin Hives Relief Syrup and Tablet Labeling

Exhibit 6 - Proposed Labeling of Silarx’s Loratadine Syrup - Hives Relief

Exhibit 7 - Side-By-Side Product Comparison of Claritin Hives Relief Syrup and Silarx Loratadine Syrup - Hives Relief

Exhibit 8 - Side-By-Side Labeling Comparison of Claritin Hives Relibf Syrup and Silarx Loratadine Syrup - Hives Relief

Exhibit 9 - Discontinued Product Listing from Orange Book and Expired Patent Information