abbreviated new drug application


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Abbreviated New Drug Application

A 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.

abbreviated new drug application

Pharmacology 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.

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.

abbreviated new drug application

,

ANDA

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.
References in periodicals archive ?
The company's Abbreviated New Drug Application product is a generic version of Gilead Sciences, Inc.
United States-based Breckenridge Pharmaceutical has filed an abbreviated new drug application with a Paragraph IV certification for dabigatran etexilate mesylate capsules EQ 75mg and EQ 150mg strengths, which is a generic version of Boehringer Ingelheim's Pradaxa, it was reported on Friday.
Synovics intends to file Abbreviated New Drug Applications (ANDAs) with the FDA for its oral controlled-release generic drugs.
United States-based Momenta Pharmaceuticals (MNTA:NASDAQ GS), has received the abbreviated new drug application for three-times-a-week generic, Copaxone (glatiramer acetate injection, 40mg/mL), submitted by Sandoz from the US Food and Drug Administration, it was reported on Friday.
M2 PHARMA-September 1, 2014-Momenta Pharmaceuticals's Copaxone receives abbreviated new drug application for Copaxone from US Food and Drug Administration
Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Mometasone Furoate Topical Solution USP, 0.
M2 PHARMA-July 10, 2014-Perrigo receives final approval for abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets
M2 EQUITYBITES-July 10, 2014-Perrigo receives final approval for abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets
M2 EQUITYBITES-May 29, 2014-Actavis files Abbreviated New Drug Application to market Saxagliptin Hydrochloride Tablets
M2 PHARMA-May 29, 2014-Actavis files Abbreviated New Drug Application to market Saxagliptin Hydrochloride Tablets
Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Doxycycline Monohydrate Tablets 50mg and 100mg; the first generic approval of this product.
Ireland-based Perrigo Company has received final approval on its Abbreviated New Drug Application for azelastine hydrochloride nasal spray (0.

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