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TABLE OF CONTENTS

1.    APPLICATION FORM FOR REGISTRATION OF A DRUG FOR HUMAN USE 
(Form N.D.A: R.1) 

2.    ATTACHMENT 1A 
       Specifications of Packing Material 
       Inner Container and Outer Packing 

3.    ATTACHMENT 2A 
       Raw Material Specifications and Analytical Control Procedures 

4.    ATTACHMENT 2B 
       Method of manufacture 

5.    ATTACHMENT 2C 
       In-process Controls 

6.    ATTACHMENT 2D 
       Finished Product Specifications and Analytical Control Procedures 

7.    ATTACHMENT 2E 
       Stability Data 

8.    ATTACHMENT 2F     
       Complete Batch Record 

9.    ATTACHMENT 3A 
       Certificate of Pharmaceutical Product 

10.  ATTACHMENT 3B 
       Manufacturing Licence 

11.  ATTACHMENT 4A 
       Toxicological Data 

12.  ATTACHMENT 4B 
       Pharmacological Data and Indications 

13.  ATTACHMENT 4C 
       Therapeutic Uses 

14.  ATTACHMENT 4D 
       Clinical Information 

15.  ATTACHMENT 4E 
       Pharmacokinetic Data 

16.  ATTACHMENT 5A 
       References to Literature 

17.  ATTACHMENT 5B 
       Package Insert