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STEPHEN E LANGILLE 09/15/2011 06/13/2011 06/09/2011 N.A. 505 b 1 with Amendments dated 4/14/2011 and 7/1/2011 satisfactory responses. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER 202736Orig1s000 MICROBIOLOGY REVIEW S Product Quality Microbiology Review 9 September 2011 NDA 202-736 Drug Product Name Proprietary Non-proprietary Sklice Topical Cream Review Number Dates of Submission s Covered by this Review Submit Received Review Request - Assigned to Reviewer Submission History...
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