Subjects: Therapeutic Equivalency / Titles: Determining whether to submit an ANDA or a 505(b)(2) application / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Therapeutic Equivalency ✖ Titles Determining whether to submit an ANDA or a 505(b)(2) application ✖ Copyright Public domain ✖

1. Determining whether to submit an ANDA or a 505(b)(2) application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.