{
  "files": [
    "Module 1 Administrative information/1.1 Forms.txt",
    "Module 1 Administrative information/1.10 Dispute resolution.txt",
    "Module 1 Administrative information/1.11 Information amendment Information not covered under modules 2 to 5.txt",
    "Module 1 Administrative information/1.12 Other correspondence/1.12 info.txt",
    "Module 1 Administrative information/1.12 Other correspondence/1.12.14 Environmental analysis.txt",
    "Module 1 Administrative information/1.12 Other correspondence/1.12.17 Orphan drug designation.txt",
    "Module 1 Administrative information/1.13 Annual report.txt",
    "Module 1 Administrative information/1.14 Labeling/1.14 info.txt",
    "Module 1 Administrative information/1.14 Labeling/1.14.1.1 Draft carton and container labels.txt",
    "Module 1 Administrative information/1.14 Labeling/1.14.1.2 Annotated draft labeling text.txt",
    "Module 1 Administrative information/1.14 Labeling/1.14.1.3 Draft labeling text.txt",
    "Module 1 Administrative information/1.14 Labeling/1.14.1.5 Labeling history.txt",
    "Module 1 Administrative information/1.15 Promotional material.txt",
    "Module 1 Administrative information/1.16 Risk management plan/1.16 info.txt",
    "Module 1 Administrative information/1.16 Risk management plan/1.16.1 Risk Management (Non-REMS).txt",
    "Module 1 Administrative information/1.16 Risk management plan/1.16.2.2 Draft REMS.txt",
    "Module 1 Administrative information/1.17 Postmarketing studies/1.17 info.txt",
    "Module 1 Administrative information/1.17 Postmarketing studies/1.17.1 Correspondence regarding postmarketing commitments.txt",
    "Module 1 Administrative information/1.18 Naming/1.18 info.txt",
    "Module 1 Administrative information/1.18 Naming/1.18.1 Proprietary names.txt",
    "Module 1 Administrative information/1.18 Naming/1.18.2 Biological Proper Name Suffix.txt",
    "Module 1 Administrative information/1.2 Cover letters.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3 info.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1 info.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1.1 Change of address or corporate name.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1.2 Change in contact agent.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1.3 Change in sponsor.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1.4 Transfer of obligation.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.1 Contact sponsor applicant information/1.3.1.5 Change in ownership of an application or reissuance of license.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.2 Field copy certification.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.3 Debarment certification.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.4 Financial certification and disclosure.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.5 Patent and exclusivity/1.3.5 info.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.5 Patent and exclusivity/1.3.5.1 Patent information.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.5 Patent and exclusivity/1.3.5.2 Patent certification.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.5 Patent and exclusivity/1.3.5.3 Exclusivity claim.txt",
    "Module 1 Administrative information/1.3 Administrative information/1.3.6 Tropical disease priority review voucher.txt",
    "Module 1 Administrative information/1.4 References/1.4 info.txt",
    "Module 1 Administrative information/1.4 References/1.4.1 Letter of authorization.txt",
    "Module 1 Administrative information/1.4 References/1.4.2 Statement of right of reference.txt",
    "Module 1 Administrative information/1.4 References/1.4.3 List of authorized persons to incorporate by reference.txt",
    "Module 1 Administrative information/1.4 References/1.4.4 Cross-reference to previously submitted information.txt",
    "Module 1 Administrative information/1.5 Application status.txt",
    "Module 1 Administrative information/1.6 Meetings/1.6 info.txt",
    "Module 1 Administrative information/1.6 Meetings/1.6.1 Meeting request.txt",
    "Module 1 Administrative information/1.6 Meetings/1.6.2 Meeting background materials.txt",
    "Module 1 Administrative information/1.6 Meetings/1.6.3 Correspondence regarding meetings.txt",
    "Module 1 Administrative information/1.7 Fast Track/1.7 info.txt",
    "Module 1 Administrative information/1.7 Fast Track/1.7.1 Fast track designation request.txt",
    "Module 1 Administrative information/1.7 Fast Track/1.7.2 Fast track designation withdrawal request.txt",
    "Module 1 Administrative information/1.7 Fast Track/1.7.3 Rolling review request.txt",
    "Module 1 Administrative information/1.7 Fast Track/1.7.4 Correspondence regarding fast track rolling review.txt",
    "Module 1 Administrative information/1.8 Special protocol assessment request/1.8 info.txt",
    "Module 1 Administrative information/1.8 Special protocol assessment request/1.8.1 Clinical study.txt",
    "Module 1 Administrative information/1.8 Special protocol assessment request/1.8.2 Carcinogenicity study.txt",
    "Module 1 Administrative information/1.8 Special protocol assessment request/1.8.3 Stability study.txt",
    "Module 1 Administrative information/1.8 Special protocol assessment request/1.8.4 Animal efficacy study for approval under the animal rule.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9 info.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9.1 Request for waiver of pediatric studies.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9.2 Request for deferral of pediatric studies.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9.3 Request for pediatric exclusivity determination.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9.4 Proposed pediatric study request and amendments.txt",
    "Module 1 Administrative information/1.9 Pediatric administrative information/1.9.6 Other correspondence regarding pediatric exclusivity or study plans.txt",
    "Module 1 Administrative information/m1 info.txt",
    "Module 2 Summaries/2.2 Introduction to summary.txt",
    "Module 2 Summaries/2.3 Quality overall summary/2.3 info.txt",
    "Module 2 Summaries/2.3 Quality overall summary/2.3.A.1 Facilities and equipment.txt",
    "Module 2 Summaries/2.3 Quality overall summary/2.3.A.2 Adventitious agents safety evaluation.txt",
    "Module 2 Summaries/2.3 Quality overall summary/2.3.P Drug product.txt",
    "Module 2 Summaries/2.3 Quality overall summary/2.3.S Drug substance.txt",
    "Module 2 Summaries/2.4 Nonclinical overview.txt",
    "Module 2 Summaries/2.5 Clinical overview.txt",
    "Module 2 Summaries/2.6.2 Pharmacology written summary.txt",
    "Module 2 Summaries/2.6.4 Pharmacokinetic written summary.txt",
    "Module 2 Summaries/2.6.6 Toxicology written summary.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7 info.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7.2 Summary of Clinical Pharmacology studies.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7.3 Summary of Clinical Efficacy.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7.4 Summary of Clinical Safety.txt",
    "Module 2 Summaries/2.7 Clinical summary/2.7.6 Synopses of individual studies.txt",
    "Module 2 Summaries/m2 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.A.1 Facilities and Equipment.txt",
    "Module 3 Quality/3.2 Body of data/3.2.A.2 Adventitious agents safety evaluation.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.1 Description and composition of the drug product.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.2 Pharmaceutical development.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.3 Manufacture/3.2.P.3 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.3 Manufacture/3.2.P.3.1 Manufacturer(s).txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.3 Manufacture/3.2.P.3.3 Description of Manufacturing Process and Process Controls.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.3 Manufacture/3.2.P.3.5 Process Validation and or Evaluation.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.4 Control of excipients.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.5 Control of drug product/3.2.P.5 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.5 Control of drug product/3.2.P.5.1 Specification(s).txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.5 Control of drug product/3.2.P.5.4 Batch Analyses.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.5 Control of drug product/3.2.P.5.6 Justification of Specification(s).txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.7 Container closure system.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.8 Stability/3.2.P.8 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.8 Stability/3.2.P.8.1 Stability Summary and Conclusion.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.8 Stability/3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment.txt",
    "Module 3 Quality/3.2 Body of data/3.2.P Drug product/3.2.P.8 Stability/3.2.P.8.3 Stability Data.txt",
    "Module 3 Quality/3.2 Body of data/3.2.R Regional information.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.1 General information.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.1 Manufacturer(s).txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.2 Description of Manufacturing Process and Process Controls.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.3 Control of Materials.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.4 Controls of Critical Steps and Intermediates.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.5 Process Validation and or Evaluation.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.2 Manufacture/3.2.S.2.6 Manufacturing Process Development.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.3 Characterization/3.2.S.3 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.3 Characterization/3.2.S.3.1 Elucidation of Structure and other Characteristics.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.3 Characterization/3.2.S.3.2 Impurities.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.4 Control of drug substance/3.2.S.4 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.4 Control of drug substance/3.2.S.4.1 Specification.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.4 Control of drug substance/3.2.S.4.2 Analytical Procedures.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.4 Control of drug substance/3.2.S.4.3 Validation of Analytical Procedures.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.4 Control of drug substance/3.2.S.4.4 Batch Analyses.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.5 Justification of Specification.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.5 Reference standards or materials.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.6 Container closure systems.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.7 Stability/3.2.S.7 info.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.7 Stability/3.2.S.7.1 Stability Summary and Conclusions.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.7 Stability/3.2.S.7.2 Post Approval Stability Protocol and Stability Commitment.txt",
    "Module 3 Quality/3.2 Body of data/3.2.S Drug substance/3.2.S.7 Stability/3.2.S.7.3 Stability Data.txt",
    "Module 3 Quality/3.3 Literature references.txt",
    "Module 3 Quality/m3 info.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2 info.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.1 Pharmacology/4.2.1 info.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.1 Pharmacology/4.2.1.1 Primary pharmacodynamics.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.1 Pharmacology/4.2.1.2 Secondary pharmacodynamics.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.1 Pharmacology/4.2.1.3 Safety pharmacology.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.2.3 Distribution.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.1 Single dose toxicity.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.2 Repeat dose toxicity.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.3 Genotoxicity.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.4 Carcinogenicity.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.5 Reproductive and developmental toxicity.txt",
    "Module 4 Nonclinical Study Reports/4.2 Study reports/4.2.3.7.2 Immunotoxicity.txt",
    "Module 4 Nonclinical Study Reports/4.3 Literature references.txt",
    "Module 4 Nonclinical Study Reports/m4 info.txt",
    "Module 5 Clinical Study Reports/5.2 Tabular listing of all clinical studies.txt",
    "Module 5 Clinical Study Reports/5.3.1.4 Reports of bioanalytical and analytical methods for human studies.txt",
    "Module 5 Clinical Study Reports/5.3.3.2 Patient PK and initial tolerability Study reports and related information.txt",
    "Module 5 Clinical Study Reports/5.3.4.2 Patient PD and PK PD Study reports and related information.txt",
    "Module 5 Clinical Study Reports/5.3.5.1 Study reports and related information of controlled clinical studies pertinent to the claimed indication.txt",
    "Module 5 Clinical Study Reports/5.3.5.2 Study reports and related information of uncontrolled clinical studies.txt",
    "Module 5 Clinical Study Reports/5.3.5.3 Reports of analyses of data from more than one study.txt",
    "Module 5 Clinical Study Reports/5.3.5.4 Other Study reports and related information.txt",
    "Module 5 Clinical Study Reports/5.3.6 Reports of postmarketing experience.txt",
    "Module 5 Clinical Study Reports/5.4 Literature references.txt",
    "Module 5 Clinical Study Reports/m5 info.txt"
  ]
}