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Re: The ELTP King post# 289498

Thursday, 05/17/2018 12:08:58 PM

Thursday, May 17, 2018 12:08:58 PM

Post# of 403482
Hopefully Elite doesn't have to do another fed BE study for SequestOx, but chances are pretty good they may have to.

And the timelines for all ANDAs submitted are guestimates. So far this FDA
under Gottlieb is no different than the FDA under Califf.

So Elite has had to do a cut tablet stability on Percocet. Norco was also mentioned, but Elite has decided to pass on Norco for now while addressing
the current ANDA Elite/SunGen will be submitting.
That will make 6 ANDAs and one NDA.
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