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Directory Results for CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022036Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS Department of Health and Human Services Food and Drug Administration PATENT INATION SUBMITTED WITH THE FILING OF AN to CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022372Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review April 7, 2009 NDA: 22372 Drug Product Name Proprietary: Nonproprietary: Review Number: SUPREP Sodium - -

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022036Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS Department of Health and Human Services Food and Drug Administration PATENT INATION SUBMITTED WITH THE FILING OF AN
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022150Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA 22150, SDN 21 Submission Date February 25, 2011 Brand Name -
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022305Orig1s000 CHEMISTRY REVIEW(S) This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature -
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022372Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review April 7, 2009 NDA: 22372 Drug Product Name Proprietary: Nonproprietary: Review Number: SUPREP Sodium - -