FDA LODINE NDA 018922 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for LODINE, NDA 018922. The package contains 7 FDA documents totaling 82 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
• 4 supplemental submissions represented
• 1 FDA review document
• 3 approval letters
• 3 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 018922
Product: LODINE
Sponsor: WYETH PHARMS INC
Documents: 7
Pages: 82
Coverage: Original approval + 4 supplemental submissions represented