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Re: DewDiligence post# 81116

Monday, 07/20/2009 7:34:09 PM

Monday, July 20, 2009 7:34:09 PM

Post# of 257275
The key distinction between the two cases is that the DDSS application is an NDA while the NVS/MNTA application is an ANDA. As you probably know, ANDA’s do not have prescribed timelines.

Thanks, I see from a November 2008 press release that DDSS had a 7/18/09 PDUFA date, which the FDA obviously satisfied.

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