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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20905/S014 Events Pharmaceuticals, Inc. Attention: Jay Kramer Associate Specialist,
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Snda-i1 approval is effective on the date specified in the approval document.
The applicant or holder of the approval is required to file the snda-i1 approval.
The snda-i1 approval should be filled out according to the instructions provided by the regulatory authority.
The purpose of snda-i1 approval is to update or modify an existing approved product.
The snda-i1 approval must include details of the requested changes and supporting data.
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