FDA LOTREL NDA 020364 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LOTREL, NDA 020364. The package contains 42 FDA documents totaling 399 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
• 23 supplemental submissions represented
• 1 FDA review document
• 22 approval letters
• 19 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 020364
Product: LOTREL
Sponsor: SANDOZ
Documents: 42
Pages: 399
Coverage: Original approval + 23 supplemental submissions represented