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Re: lizzy241 post# 329840

Tuesday, 03/16/2021 4:22:42 PM

Tuesday, March 16, 2021 4:22:42 PM

Post# of 425918
Lizzy, I don't question the fact that Dr Reddy has a valid ANDA. I don't know this to a certainty. If my math is correct they are past the deadline to launch. In order to keep the ANDA FDA required an explanation as to why the launch didn't happen on time. Somewhere on the FDA website there should be a letter with an explanation from Dr Reddy. We were unable to launch on time due to lack of API, legal considerations, ect... If someone finds that letter it might answer a lot of questions.
Sleven,
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