Subjects: Humans and Investigational New Drug Application / Titles: ANDA submissions--amendments to abbreviated new drug applications under GDUFA - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Humans ✖ Subjects Investigational New Drug Application ✖ Titles ANDA submissions--amendments to abbreviated new drug applications under GDUFA ✖

1. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.