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Sunday, December 22, 2013 7:22:08 PM
RapiMed(R) for children does NOT require FDA approval. Its active ingredient is acetaminophen, which is a monograph product identified by FDA as safe. So we don't need approval.
Today I learned from the CEO of the product manufacturer, Capricorn, that it has procured an "NDC" number and informed the FDA of its intentions to market, distribute, and sell this product. "So we are absolutely ready to launch."
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