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Directory Results for CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022405Orig1s000 REMS Initial REMS Approval: 04/2011 NDA 22-405 Vandetanib Kinase inhibitor AstraZeneca Pharmaceuticals LP 1800 Concord Pike P - accessdata fda to CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022454Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS EXCLUSIVITY SUMMARY NDA # 22-454 Trade Name Generic Name Ioflupane I-123 Applicant Name GEHealthcare Approval -

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022405Orig1s000 REMS Initial REMS Approval: 04/2011 NDA 22-405 Vandetanib Kinase inhibitor AstraZeneca Pharmaceuticals LP 1800 Concord Pike P - accessdata fda
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022432Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS Reference ID: 2864298 Reference ID: 2864298 Reference ID: 2864298 Reference ID: 2864298 EXCLUSIVITY SUMMARY NDA # 022432
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022439Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) CLINICAL PHARMACOLOGY REVIEW (RESUBMISSION DATED DECEMBER 8, 2010) NDA: 22439/SDN 22 Type of Submission: - - -
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022454Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS EXCLUSIVITY SUMMARY NDA # 22-454 Trade Name Generic Name Ioflupane I-123 Applicant Name GEHealthcare Approval -