1. Referencing approved drug products in ANDA submissions Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020 Subject(s): Drug ApprovalDrugs, GenericReference Books, MedicalTherapeutic EquivalencyUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
2. Referencing approved drug products in ANDA submissions Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020 Subject(s): Drug ApprovalDrug EvaluationDrug LabelingDrugs, GenericUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration