FDA LOVENOX NDA 020164 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LOVENOX, NDA 020164. The package contains 77 FDA documents totaling 2,200 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
• 49 supplemental submissions represented
• 28 FDA review documents
• 31 approval letters
• 18 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 020164
Product: LOVENOX
Sponsor: SANOFI AVENTIS US
Documents: 77
Pages: 2,200
Coverage: Original approval + 49 supplemental submissions represented