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Directory Results for CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202278Orig1s000 LABELING ( HIGHLIGHTS OF PRESCRIBING INATION These highlights do not include all the information needed to use ZECUITY safely and effectively - accessdata fda to CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202570Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OFFICE OF CLINICAL PHARMACOLOGY GENOMICS GROUP REVIEW NDA/BLA Number Submission Date Applicant Name Generic - -

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202278Orig1s000 LABELING ( HIGHLIGHTS OF PRESCRIBING INATION These highlights do not include all the information needed to use ZECUITY safely and effectively - accessdata fda
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202450Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review 06 DEC 2011 NDA: 202450 Drug Product Name Proprietary: Nonproprietary: (proposed) Aclidinium bromide - -
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202535Orig1s000 OTHER REVIEW(S) PMR/PMC Development Template This template should be completed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action -
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202570Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OFFICE OF CLINICAL PHARMACOLOGY GENOMICS GROUP REVIEW NDA/BLA Number Submission Date Applicant Name Generic - -