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 ApprovalDrugs, InvestigationalInvestigational New Drug ApplicationDrug LabelingTherapeutic EquivalencyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
