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Re: fabius post# 21027

Friday, 12/09/2016 10:55:09 AM

Friday, December 09, 2016 10:55:09 AM

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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202842Orig1s000ltr.pdf

Here I the link to the FDA approval letter that stated the within 14 days to submit the new labeling.
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