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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022460Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review December 22, 2009, NDA: 22-460 Amendment Drug Product Name Proprietary:
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The information that must be reported on the 22-460 amendment - accessdata includes the specific record or information being amended, details of the changes or updates being made, and any supporting documentation if required. It is important to provide accurate and complete information to facilitate the amendment process.
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