New Drug Applications (NDAs)

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

• Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated Products
• Complete List of Currently Approved New Drug Application (NDA) Submissions

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Related Information

• New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
• Transfer of Therapeutic Products to the Center for Drug Evaluation and Research - Archived