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 said the Abbreviated New Drug Application (ANDA) for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg is the therapeutic equivalent to the reference listed drug, Marinol Capsules 2.5 mg, 5 mg and 10 mg from AbbVie Inc.
Generic pharmaceutical company Amerigen Pharmaceuticals Limited revealed on Tuesday the receipt of final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for cyclophosphamide capsules in 25mg and 50mg.
M2 PHARMA-March 21, 2018-Amerigen wins US FDA final approval for Abbreviated New Drug Application for cyclophosphamide capsules to treat cancers
The United States Food and Drug Administration (US FDA) has sanctioned TWi Pharmaceuticals on its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.
has received approval from the Food and Drag Administration for its Abbreviated New Drug Application for over-the-counter ranitidine, 150 mg (regular and cool mint), a genetic version of Zantac 150, which is indicated for the relief of heartburn associated with acid indigestion and sour stomach, and for the prevention of heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages.
FDA approval on its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and has immediately initiated commercialization activities.
Glenmark Pharmaceuticals announced that Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics, has won final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1%, the generic version of Vanos Cream by Medicis.
The United States Food and Drug Administration (FDA) has granted tentative approval to Impax Laboratories Inc (NASDAQ: IPXL), a specialty pharmaceutical company, for its Abbreviated New Drug Application (ANDA) for the generic version of Coreg CR (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg, it was reported on Friday.
The US Food and Drug Administration has given final approval for the Abbreviated New Drug Application (ANDA), being manufactured and supplied by its parent company, Laboratorios Dr.
Watson Laboratories, a subsidiary of Watson Pharmaceuticals Inc., has filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, seeking approval to market a generic version of Combigan.
FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's disease and the treatment of mild to moderate dementia associated with Parkinson's disease.
The United States Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application for United States-based Impax Laboratories, Incorporated's (NASDAQ: IPXL) generic version of Renvela[R] (sevelamer carbonate) tablets, 800 mg, it was reported on Monday.

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