NDA 20-358

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TABLE OF CONTENTS

 

 

Page

 

 

90 p.o. toxicity in rats............................................................................................................

3

 

 

Segment II reproduction in rats............................................................................................

8

 

 

Genotoxicity studies...............................................................................................................

 

                Ames tests................................................................................................................

10

                In vivo cytogenetics in rats......................................................................................

10

 

 

Summary..................................................................................................................................

12

 

 

Labeling...................................................................................................................................

14

 

 

Evaluation...............................................................................................................................

19

 

 

Recommendations..................................................................................................................

20

 

 

 


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