SOURCES, VERSIONS & WHAT CHANGED

Drugs@FDA reference: initial ACD release

Our first prepared Drugs@FDA reference connects application context, recorded submission statuses and document links.

Source capture and ACD preparation

This fixed source capture is dated October 16, 2026. FDA’s download page reports October 16 as its last-updated date; the ZIP members are timestamped October 15. Neither establishes an exhaustive event-coverage cutoff. This is the first ACD release, with no previous ACD edition to compare.

Useful relationships, explicit limits

Submissions retain their application, type and number, with recorded status dates, FDA class descriptions and independently counted document/action-category relationships. Applications, drug products, documents and action categories remain separate tables. The result supports application research without pretending that each submission belongs to every product or NDC.

Source quality and accounting

All 966,972 source rows have an outcome. We retain 5,377 submissions with missing application records and leave their type and sponsor blank. The 129 application-level documents are distinct from the 23 other documents lacking a matching submission. Three action rows with all-zero application identifiers are quarantined with their original cells.

Two short application numbers are normalized with original values preserved. One specifically reviewed extra-tab defect is repaired. Source January 1, 1900 dates (one submission and 1,842 documents) remain in audit fields but have blank analytical dates and review flags. Five malformed URLs and 4,128 URLs containing whitespace remain identifiable; no link is guessed or asserted reachable.

Using this edition

Try the application-portfolio Python guide or inspect the fields and complete package. The fixed edition costs $29 once; processing improvements on these inputs are included. The Orange Book reference supplies a separate patent/exclusivity view.

Sources: FDA source files and scope documentation. Recorded submission status dates are not receipt dates or a complete event log. Independent preparation; no FDA endorsement.