FDA LIPIDIL NDA 019304 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LIPIDIL, NDA 019304. The package contains 4 FDA documents totaling 531 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 2 supplemental submissions represented
• 2 FDA review documents
• 1 approval letter
• 1 labeling document
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 019304
Product: LIPIDIL
Sponsor: ABBVIE
Documents: 4
Pages: 531
Coverage: Original approval + 2 supplemental submissions represented