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InTheTrenches

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InTheTrenches

Re: Samsa post# 16891

Thursday, 08/04/2016 10:00:19 PM

Thursday, August 04, 2016 10:00:19 PM

Post# of 38634
This is the document where I saw the name/address of manufacturer is required:

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM182538.pdf

Page 8. Again, it's not clear if this is for 505(b)(2) as well as 505(b)(1).

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