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Purple Book
Database of Licensed Biological Products

Download Purple Book Data

Each monthly report is divided into two sections. The top section of the report lists the changes that occurred during that month in three different categories: updated products (U), newly approved products (N), and products added in current release (R). Updated products (U) include FDA-approved products previously in the Purple Book that experienced changes during the month, resulting in an update of the applicable product(s) information (e.g., change in applicant or proprietary name). Newly approved products (N) include those that received initial FDA-approval during the month. Products added in current release (R) include a set of products that are not newly approved but were not previously included in the database. For example, some already-approved biologic products regulated by the Center for Biologics Evaluation and Research (CBER) were added to the Purple Book for the first time as part of an August 2020 database release. The bottom section of each report contains all products in the Purple Book database for that month, including the products listed in the top section that were added or changed. For more information, visit the User Guide.

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January 2024 CSV | XLSX
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February 2020 CSV | XLSX
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