FDA TICLID NDA 019979 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for TICLID, NDA 019979. The package contains 3 FDA documents totaling 43 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
• 2 supplemental submissions represented
• 1 FDA review document
• 1 approval letter
• 1 labeling document
• 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 019979
Product: TICLID
Sponsor: ROCHE PALO
Documents: 3
Pages: 43
Coverage: Original approval + 2 supplemental submissions represented