FDA TOPAMAX NDA 020505 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for TOPAMAX, NDA 020505. The package contains 57 FDA documents totaling 2,106 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
• 32 supplemental submissions represented
• 1 FDA review document
• 29 approval letters
• 27 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 020505
Product: TOPAMAX
Sponsor: JANSSEN PHARMS
Documents: 57
Pages: 2,106
Coverage: Original approval + 32 supplemental submissions represented