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