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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for:APPLICATION NUMBER:NDA 206488/S006 Trade Name:Exodus 51Generic Name: eteplirsen injection Sponsor:Santa Therapeutics, Inc. Approval Date:
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NDA 206-488s-006 is a form used by pharmaceutical companies to report adverse events associated with their products.
Pharmaceutical companies who have received approval for their products from the FDA are required to file NDA 206-488s-006.
NDA 206-488s-006 can be filled out electronically on the FDA's website, or it can be submitted via mail or fax.
The purpose of NDA 206-488s-006 is to ensure that the FDA is informed of any adverse events associated with pharmaceutical products.
The information reported on NDA 206-488s-006 includes details of the adverse event, the product involved, and any relevant patient information.
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