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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. Beckloff Please refer to your New Drug Application NDA dated and received November 24 2015 and your amendments received December 18 2015 January 22 27 February 26 29 May 18 June 07 20 28 July 01 08 two 19 26 28 August 31 and September 19 2016 submitted pursuant to section 505 b 2 of the Federal Food Drug and Cosmetic Act...
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