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Qdossier Qsauri
"U"

unsolicited amendment
Guideline or reference source
FDAGDUFA Generic Drug User Fee Amendments 2012
Definition
an amendment with information not requested by the FDA except for those unsolicited amendments considered routine or administrative in nature and that do not require scientific review (e.g., requests for final ANDA approval, patent amendments, general correspondence, and USP monograph updates).  

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