FDA TAMBOCOR NDA 018830 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for TAMBOCOR, NDA 018830. The package contains 3 FDA documents totaling 1,901 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
• 1 supplemental submission 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 018830
Product: TAMBOCOR
Sponsor: ALVOGEN
Documents: 3
Pages: 1,901
Coverage: Original approval + 1 supplemental submission represented