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Re: imanjen13 post# 360459

Tuesday, 08/17/2021 5:42:29 PM

Tuesday, August 17, 2021 5:42:29 PM

Post# of 403269
He said 4 submissions next year and approvals the following year. They could all end up being submitted in the back half of 2022. We haven’t heard of any study results so these are either submissions based on previous studies Elite has done (doubtful) or new ones. Elite typically needed 6 months from positive bioequivalency studies to submit the ANDA.

Also, still no agreement with Sungen on next antibiotic. No word from FDA yet on antibiotic submission either…
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