FDA LESCOL XL NDA 021192 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LESCOL XL, NDA 021192. The package contains 29 FDA documents totaling 455 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
• 14 supplemental submissions represented
• 3 FDA review documents
• 13 approval letters
• 13 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 021192
Product: LESCOL XL
Sponsor: SANDOZ
Documents: 29
Pages: 455
Coverage: Original approval + 14 supplemental submissions represented