Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals

[FDA]

This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the Center for Drug Evaluation and Research (CDER). The listed NMEs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under


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