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dmlcento

04/22/20 4:44 PM

#268382 RE: sts66 #268376

sts, scroll down to "the Drug doesn't break down over time"

https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs
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CaptBeer

04/22/20 4:46 PM

#268383 RE: sts66 #268376

sts66: Here's my source for the stability requirement. About halfway down:

https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers