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Re: GermanCol post# 531363

Saturday, 11/12/2022 7:25:46 PM

Saturday, November 12, 2022 7:25:46 PM

Post# of 704654
German, I provided sources that contradict this just the other day. If you don’t have the generic name WHEN APPROVED, meaning we’ll after they’ve been in an approval context, whether because they had a rolling approval or they submitted their application without that name, the FDA and local regulators have a mechanism for providing an interim generic name.

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