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Post# of 448134
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Number sleven

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Number sleven

Re: sts66 post# 330031

Wednesday, 03/17/2021 6:08:05 PM

Wednesday, March 17, 2021 6:08:05 PM

Post# of 448134
Sts, I understand what is written and the meaning of it. FDA requires an explanation if the drug is not on the market 180 days after approval of the ANDA. Dr Reddy has had an approved ANDA for well over 200 days. That means there should be a letter of explanation somewhere. If they don't explain the issue to FDA what do you think will happen?
Sleven,
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