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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Silver Spring MD 20993NDA 022327/S004SUPPLEMENT APPROVAL Novartis Consumer Health, Inc.
Attention: Marissa M. Fletcher, Ph.D.
North
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How to fill out nda 022327s-004
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04
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05
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06
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What is nda 022327s-004?
NDA 022327s-004 is a specific application number assigned by the FDA for a new drug application.
Who is required to file nda 022327s-004?
The pharmaceutical company developing the new drug is required to file NDA 022327s-004 with the FDA.
How to fill out nda 022327s-004?
To fill out NDA 022327s-004, the pharmaceutical company must provide detailed information about the new drug, its efficacy, safety, manufacturing process, and more.
What is the purpose of nda 022327s-004?
The purpose of NDA 022327s-004 is to seek FDA approval for the marketing and sale of a new drug in the United States.
What information must be reported on nda 022327s-004?
NDA 022327s-004 must include data from clinical trials, information on the drug's mechanism of action, pharmacokinetics, pharmacodynamics, and more.
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