The following products are regulated as New Drug Applications (NDAS): Solutions used in the collection of blood and plasma donations.

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List of New Drug Applications

Information is arranged in alphabetical order by the name of the applicant.

• New Drug Applications with Supporting Documents
• Complete List of Currently Approved New Drug Application (NDA) Submissions

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Related Information

• New Drug Application (NDA) Process (CBER)
• Transfer of Therapeutic Products to the Center for Drug Evaluation and Research