FDA BACTROBAN NDA 050703 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for BACTROBAN, NDA 050703. The package contains 8 FDA documents totaling 66 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
• 4 approval letters
• 4 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 050703
Product: BACTROBAN
Sponsor: GLAXOSMITHKLINE
Documents: 8
Pages: 66
Coverage: Original approval + 4 supplemental submissions represented