FDA LIPTRUZET NDA 200153 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LIPTRUZET, NDA 200153. The package contains 21 FDA documents totaling 878 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
• 5 supplemental submissions represented
• 9 FDA review documents
• 6 approval letters
• 6 labeling documents
• 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 200153
Product: LIPTRUZET
Sponsor: ORGANON
Documents: 21
Pages: 878
Coverage: Original approval + 5 supplemental submissions represented