FDA ADALAT CC NDA 020198 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for ADALAT CC, NDA 020198. The package contains 6 FDA documents totaling 51 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
• 3 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 020198
Product: ADALAT CC
Sponsor: NORWICH
Documents: 6
Pages: 51
Coverage: Original approval + 3 supplemental submissions represented