Abbreviated New Drug Application
id:
abbreviated-new-drug-application-307-9821031
title:
Abbreviated New Drug Application
text:
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submission
brand slug:
wiki
category slug:
encyclopedia
description:
Application for US generic drug approval
original url:
https://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application
date created:
date modified:
2023-03-09T23:16:41Z
main entity:
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image:
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fields total:
13
integrity:
15