Tag: FDA ANDA approval list
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US FDA ANDA Drug Registration: Regulatory Pathway for Generic Medicines
The Abbreviated New Drug Application (ANDA) is the approval route used for generic medicines in the United States. Companies that wish to market a generic drug must submit an ANDA to the U.S. Food and Drug Administration (FDA) demonstrating that their product is equivalent to a previously approved reference listed drug (RLD). US FDA ANDA…