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What is difference between NDA & ANDA ?
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NDA means New Drug Application,sponsor of new drug must submit evidence of drug safety&effectiveness to meet FDA requirements for marketing approval,hence sponsor submits to FDA a New Drug Application(NDA)......ANDA means Abbreviated New Drug Application which is an application for US generic drug approval for an existing licensed medication or approved drug.
Thanks,
B.Gangatharan,
Caplin Point laboratory,
Puducherry.
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