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Wednesday, March 17, 2021 5:57:21 PM
Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81 and 314.98 and at section 506I of the FD&C Act. The Agency should be advised of any change in the marketing status of this drug or if this drug will not be available for sale
after approval. In particular, under section 506I(b) of the FD&C Act, you are required to
notify the Agency in writing within 180 days from the date of this letter if this drug will not
be available for sale within 180 days from the date of approval. As part of such written
notification, you must include (1) the identity of the drug by established name and
proprietary name (if any); (2) the ANDA number; (3) the strength of the drug; (4) the
date on which the drug will be available for sale, if known; and (5) the reason for not
marketing the drug after approval.
Don't know why you keep getting this ANDA stuff wrong - it's almost like you want the words to support your argument so much you see things that aren't there.
The Thought Police: To censor and protect. Craig Bruce
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