FDA IMITREX NDA 020132 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for IMITREX, NDA 020132. The package contains 14 FDA documents totaling 212 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
• 9 supplemental submissions represented
• 1 FDA review document
• 8 approval letters
• 5 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 020132
Product: IMITREX
Sponsor: GLAXOSMITHKLINE
Documents: 14
Pages: 212
Coverage: Original approval + 9 supplemental submissions represented