Abbreviated New Drug Application Archives • NCK Pharma

What is the meaning and significance of ‘First to File’ Generics?

Posted on28 Dec 2017

Tags505(j) ANDA, 505(j) is ANDA, Abbreviated New Drug Application, ANDA, First to FFile Generics

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The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us...