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NDA 203496/S011 SUPPLEMENT APPROVAL United Therapeutics Corporation Attention: Sarah Emerging, Ph.D., R.A.C. Senior Regulatory Affairs Associate 55 TW Alexander Drive PO Box 14186 Research Triangle
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NDA 203496s-011 supplement approval is a form of submission to request approval for changes or additions to an existing New Drug Application (NDA).
The pharmaceutical company or entity holding the NDA for the drug is required to file nda 203496s-011 supplement approval.
The nda 203496s-011 supplement approval form must be completed with detailed information about the proposed changes or additions to the existing NDA, along with supporting documentation.
The purpose of nda 203496s-011 supplement approval is to ensure that any changes or additions to an approved NDA meet regulatory requirements and are safe and effective.
The nda 203496s-011 supplement approval must include information on the proposed changes or additions, the rationale for the changes, any new data or studies supporting the changes, and any potential impact on the drug's safety or efficacy.
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