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jtaylor68

05/19/18 11:59 AM

#15108 RE: ShawnP123 #15105

There's no need to discuss anything about this ANDA. It comes when it comes, be this year or the next year.

Nothing was rejected. That's a matter of fact. A rejection is a material event and thus requires disclosure. This is not debatable.

How do you know there were no issues with the Rx version?