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Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. Fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must be identical to the enclosed labeling text for the package insert. O. Box 300 Raritan NJ 08869-0602 Dear Dr. Kollath Please refer to your New Drug Application NDA dated April 19 2016 received April 19 2016 and your amendments...

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Janssen Pharmaceuticals Inc is a pharmaceutical company that focuses on developing and producing medications to improve health outcomes.

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