FDA TOPROL-XL NDA 019962 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for TOPROL-XL, NDA 019962. The package contains 36 FDA documents totaling 345 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
• 22 supplemental submissions represented
• 5 FDA review documents
• 18 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 019962
Product: TOPROL-XL
Sponsor: MELINTA THERAP
Documents: 36
Pages: 345
Coverage: Original approval + 22 supplemental submissions represented