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Pre-ANDA Litigation, Chapter 18: ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review
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Document Date: 2014-08-11 11:16:58

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Boston / Philadelphia / Chicago / /

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Staley Generic Pharmaceuticals / API / Staley Pharmaceuticals / Duane Morris LLP / /

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United States / India / /

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USD / /

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FDA Phase / /

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Facility Fees Anyone / Additional API facility / Staley Pharmaceutical’s API facility / Final Dosage Form Facility / A facility / /

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facility manufacturing / drug product / target products / makes drug products / active pharmaceutical ingredient / manufacturing site / manufacturing / generic drug products / drug products / /

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disease / /

Movie

A Fistful of Dollars / /

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Food and Drug Administration / Congress / federal government / US Federal Reserve / FDA / Center for Drug Evaluation and Research / office of Generic Drugs / /

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Kevin M. Nelson / Kenneth L. Dorsney / Fees Anyone / Christopher S. Kroon / Matthew C. Mousley / Patrick C. Gallagher / /

Position

federal judge / Editor-in-Chief / outside counsel / judge / /

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Industry / Prior Approval Supplement / Generic Drug / developing / ANDA / /

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XML / L / /

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