207154orig1s000 - food and drug administration mock up container and calton labels. additionally,...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207154Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207154Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 3: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

2

Attachment - 1 (Review of CMC Sections of the Finalized Labeling and Labels)

Page 4: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 5: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 6: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 7: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 8: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 9: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 10: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

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Page 12: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 13: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 14: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 15: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 16: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 17: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 18: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 19: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 20: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 21: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 22: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 23: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 24: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 25: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 26: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 27: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 28: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 29: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 30: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 31: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 32: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 33: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 34: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 35: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

Page 36: 207154Orig1s000 - Food and Drug Administration mock up container and calton labels. Additionally, the applicant also agreed to all the CMC changes made to the package insert. All the

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