FDA CAMPRAL NDA 021431 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for CAMPRAL, NDA 021431. The package contains 6 FDA documents totaling 49 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
• 3 approval letters
• 3 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 021431
Product: CAMPRAL
Sponsor: FOREST LABS
Documents: 6
Pages: 49
Coverage: Original approval + 2 supplemental submissions represented