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DewDiligence

01/13/11 11:49 AM

#112472 RE: bladerunner1717 #112462

For all practical purposes, an authorized generic is identical to its branded counterpart. In some cases, an AG is actually the same pill with a different marking. The AG itself does not require FDA approval because it’s a license rather than a new product; however, if the AG is manufactured at a different site from its branded counterpart, the facility where the AG is made is subject to FDA inspection.