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DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly Pharm.D. Associate Director Advertising and Promotions Bayer HealthCare Pharmaceuticals Inc. 6 West Belt Wayne NJ 07470-6806 RE NDA 21-225 -releasing intrauterine system MACMIS 18166 Dear Dr.

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