USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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Pending <strong>Monograph</strong>s• Sponsors– Who have filed or intend to file with FDA an AbbreviatedNew Drug Application (ANDA) or Abbreviated New AnimalDrug Application (ANADA)– Who have submitted a Drug Master File (DMF) to FDA– Whose substance is or will be the subject of a Time <strong>and</strong>Extent Application or citizen petition to amend an FDAOTC drug monograph• Documentation– Statement of intent to file an ANDA or ANADA within sixmonths– Copy of the DMF filing letter
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