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sts66

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sts66

Re: Number sleven post# 329847

Tuesday, 03/16/2021 6:13:24 PM

Tuesday, March 16, 2021 6:13:24 PM

Post# of 448110

In order to keep the ANDA FDA required an explanation as to why the launch didn't happen on time



What makes you think that? Don't confuse the 1st ANDA filer having to launch within a 180 window of exclusivity with an approved ANDA have to launch, period, or FDA withdraws the ANDA - FDA cannot make business decisions for generics.

The Thought Police: To censor and protect. Craig Bruce

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