Tag: What is ANDA approved by the FDA?
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US FDA ANDA Drug Registration: Roadmap for Generic Drug Approval in the USA
Generic medicines provide affordable treatment options while meeting the same standards of quality, safety, and performance as brand-name drugs. To legally market a generic drug in the United States, manufacturers must submit an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). US FDA ANDA drug registration and approval confirms that…