I) Summary

1. Drug name

2. Certified document

Certified document of class 5.2 product by register classification

3. Purpose and basis of subject selection

4. Self-assessment report

5. Listed Licensee information

6. Innovator product information

7. Package insert, drafting Instruction and related reference

8. Design comps of product packaging and label

II) Drug Substance (API)

Note: Figures in bracket are numbers in CTD format, the same below) Summary of Pharmaceutical Study Information of Drug Substance (API)

10. (3.2.S) Pharmaceutical Applification Files of Drug Substance (API)

10.1. (3.2.S.1) General Information

10.2. (3.2.S.2) Manufacture

10.3. (3.2.S.3) Characterization

10.4. (3.2.S.4) Control of Drug Substance

10.5. (3.2.S.5) Reference Standards

10.6. (3.2.S.6) Container Clouser System

10.7. (3.2.S.7) Stability

III) Drug Product

11. (2.3.P) Summary of Pharmaceutical Study Information of Drug Product

12. (3.2.P) Pharmaceutical Application Files of Drug Product

12.1. (3.2.P.1) Description and Composition of the Drug Product

12.2. (3.2.P.2) Pharmaceutical Development

12.3. (3.2.P.3) Manufacturer

12.4. (3.2.P.4) Control of Expients

12.5. (3.2.P.5) Control of Drug Product

12.6. (3.2.P.6) Reference Standards

12.7. (3.2.P.7) Stability

13. (2.4.P) Summary of Nonclinical Study Information of Drug Product

14. Summary of Nonclinical Application Files of Drug Product

14.1. (4.2.2) Pharmacokinetics

14.2. (4.2.3) Toxicology

5. (2.5.P.) Summary of Clinical Study Information of Drug Product

6. Summary of Clinical Applification Files of Drug Product

16.1. (5.2) Summary of Clinical Trial Items

16.2. (5.3) Bioequivalence Test Report

16.2.1. (5.3.1.2.1) Fasting Bioequivalence Test Report

16.2.2. (5.3.1.2.2) Postprandial Bioequivalence Test Report

16.2.3. (5.3.1.4) Report of Method Validation and Biological Sample Analysi

16.3. (5.3.5.4) Other clinical trial report

16.4. (5.4) References