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 -- standardsInvestigational New Drug ApplicationDrug ApprovalHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022 Subject(s): Capsules -- standardsDrugs, Generic -- standardsGovernment RegulationTablets -- standardsUnited StatesUnited States. Food and Drug Administration
