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Regulatory Specialist Three Corporate Drive Lake Zurich IL 60047 Dear Ms. Rebbapragada Please refer to your New Drug Application NDA dated January 28 2011 received January 28 2011 submitted pursuant to section 505 b 2 of the Federal Food Drug and Cosmetic Act FDCA for Kabiven and Perikabiven amino acids electrolytes dextrose and lipid injectable We acknowledge receipt of your amendments dated March 10 2011 April 6 2011 April 25 2011 May 10 2011 June 17 2011 July 7 2011 July 27 2011 August 5...
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The Center for Drug Evaluation is a regulatory body responsible for evaluating and approving drugs for market.
Pharmaceutical companies and drug manufacturers are required to file center for drug evaluation.
Center for drug evaluation forms can be filled out online or submitted in person to the regulatory agency.
The purpose of center for drug evaluation is to ensure the safety and efficacy of drugs before they are approved for market.
Center for drug evaluation forms typically require information on the drug's ingredients, manufacturing process, and clinical trial data.
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