new chemical entity

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new chemical entity2016-11-15T13:01:05+00:00

new chemical entity 

THERAPEUTICS

Definition A drug which contains no active moiety that has been (previously) approved by FDA in any other application submitted under §505(b) of the Federal Food, Drug, & Cosmetic Act

Reference www.fda.gov/cder/about/smallbiz/exclusivity.htm

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