NDA
20-358 |
2 |
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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