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Page 1: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208401Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 3: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 4: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 5: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 6: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 7: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 8: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 9: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 10: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 11: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 12: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 13: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 14: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 15: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 16: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 17: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 18: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery
Page 19: 208401Orig1s000 - Food and Drug Administration€¦ · OVERALL ASSESSNŒNT AND SIGNATURES ... The test method for microbial limits and were verified to be ... Validation of the recovery

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