APPLICATION NUMBER:
21-515
Reviews/Information Included in this NDA Review. |
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Approval
Letter |
X |
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Approvable
Letter 1 |
X |
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Approval
Letter 2 |
|
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Final
Printed Labeling |
|
|
Medical
Review(s) |
X |
|
Chemistry
Review(s) |
X |
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EA/FONSI |
|
|
Pharmacology
Review(s) |
|
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Statistical
Review(s) |
|
|
Microbiology
Review(s) |
|
|
Clinical
Pharmacology/Biopharmaceuticals Review(s) |
X |
|
Administrative/Correspondence
Document(s) |
X |
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