9/11/2023 0 Comments Script google book downloaderReference standard data updates to the Orange Book (January 2017).Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act (August 2020).Referencing Approved Drug Products in ANDA Submissions (October 2020).Evaluation of Therapeutic Equivalence (July 2022).Orange Book Questions and Answers (July 2022).Pre-Hatch-Waxman Abbreviated New Drug Applications (PANDA) in the Orange Book (PDF - 1.76MB).Reference Listed Drugs by ANDA Reference Standard List (PDF - 115 KB).Additions/Deletions for Prescription and OTC Drug Product Lists. zip file)įor additional information, such as descriptions of data fields in the Orange Book Search, please see Orange Book Data Files.
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