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jour_trader

07/18/16 6:42 PM

#215443 RE: mrwrn2010 #215388

Great question. Here is a couple links I have used in the past to distinguish NDA vs ANDA requirements. Lots of similarities. ANDA's on avg take much longer to approve - around 3 years I believe, but we have ADT at play so this will be interesting to see.

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.http://www.lachmanconsultants.com/2013/08/june-approval-times-for-andas-a-snapshot-in-time/