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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. The status of this postmarketing study must be reported annually according to 21 CFR 314. 81 and section 505B a 3 C of the FDCA. Beckloff Please refer to your New Drug Application NDA dated and received June 30 2015 and your amendments received July 14 September 14 30 October 16 30 November 16 23 December 10 2015 and January...
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Silvergate Pharmaceuticals Inc is a pharmaceutical company that focuses on developing and distributing generic pharmaceutical products.
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