The information in Drugs@FDA comes from:
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Document Archiving, Reporting, and Regulatory Tracking System (DARRTS). DARRTS is used by FDA staff to track information about the receipt and review status of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) for therapeutic biologics.
