abbreviated new drug application(redirected from ANDA)
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Abbreviated New Drug ApplicationA simplified submission to the US Food & Drug Administration (FDA) requesting authorization to market a new formulation of an existing drug or an investigational drug similar to an already approved drug, for which both its therapeutic indications and formulation were previously approved by the FDA.
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abbreviated new drug applicationPharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar drug. See Me too drug.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.
ab·bre·vi·a·ted new drug ap·pli·ca·tion(ă-brē'vē-ā-tĕd nū drŭg ap'li-kā'shŭn)
A request by a pharmaceutical company to market and sell a pharmaceutical that is essentially the same as another, which has already been granted such approval.
Medical Dictionary for the Health Professions and Nursing © Farlex 2012
abbreviated new drug application,
A formal request to the U.S. Food and Drug Administration to approve a generic drug that is a copy of a patented agent already approved for use.
Medical Dictionary, © 2009 Farlex and Partners