FDA CAPOTEN NDA 018343 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for CAPOTEN, NDA 018343. The package contains 14 FDA documents totaling 125 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
• 8 supplemental submissions represented
• 8 approval letters
• 6 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 018343
Product: CAPOTEN
Sponsor: AARXION ANDA HLDING
Documents: 14
Pages: 125
Coverage: Original approval + 8 supplemental submissions represented