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abbreviated new drug application

   Also found in: Acronyms 0.01 sec.
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.


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Adams filed the lawsuit in response to Perrigo's notification that it filed a Paragraph IV Certification in connection with its Abbreviated New Drug Application (ANDA), which seeks FDA approval to engage in the commercial manufacture, use or sale of guaifenesin 600 mg single-ingredient, extended-release tablets (equivalent to Adams' Mucinex SE), prior to the expiration of the '252 patent.
Nabi filed the lawsuit on the basis that Roxane's submission of an Abbreviated New Drug Application (ANDA) with the FDA and its proposed generic product infringe on a patent held by the company that expires in 2021.
has received final FDA approval for its Abbreviated New Drug Application (ANDA) for tamoxifen citrate tablets in 10 mg and 20 mg strengths.
 
 
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