Difference between NDA and ANDA?

 Difference between NDA and ANDA?

Asked on June 25, 2020 in Pharma.
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NDA  means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.

ANDA  means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.

Answered on June 29, 2020.
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