FDA Orange Book - Approved Drug Products

FDA Orange Book Monthly Additions and Deletions to Prescription and OTC Drug Product Lists

The FDA Orange Book publishes monthly index files documenting new additions and deletions to its list of approved prescription and OTC drug products, covering January 2021 through March 2026. Products are flagged with symbols indicating additions (>ADD>), deletions (>DLT>), or discontinued marketing status (@). The index is a reference companion to the cumulative Orange Book and its supplements.