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Generic Drug ANDA review process

Generic Drug ANDA review process - Letter Approval Withheld...

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1 Generic Drug (ANDA) Review Process Bioequivalence Review Labeling Review Chemistry & Micro Review ANDA Acceptable & Complete Application Review N Chem/Micro OK? Labeling OK? Bioequivalence OK? PreApproval Inspection Results OK? Not Approvable
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Unformatted text preview: Letter Approval Withheld until Results Satisfactory Bio Deficiency Letter APPROVED ANDA N N N N Y Y Y Y Y Refuse to Receive Letter Source: FDA’s Office of Generic Drugs Request for Plant Inspection...
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  • Spring '11
  • Tackett
  • Generic drug, Food and Drug Administration, Generic drugs, Drug Price Competition and Patent Term Restoration Act, Micro Review, Abbreviated New Drug Application

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