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In the 04 b 4 October 2012 Class 2 resubmission Tris Pharma for Burkholderia cepacia complex BCC species. 12/31/2012 BRYAN S RILEY I concur. 30 AUG 2011 carbinoxamine maleate per 5 mL 7 JUL 2011 Conclusion Approvable pending revision of the deficiencies on page 9. We refer you to Envir. Microbiol. 13 1 1-12 2011 for more information on the B. cepacia complex of organisms. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER 22-556Orig1s000 MICROBIOLOGY REVIEW S Product Quality...
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