FDA PARLODEL NDA 017962 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for PARLODEL, NDA 017962. The package contains 10 FDA documents totaling 104 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
• 5 supplemental submissions represented
• 5 approval letters
• 5 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 017962
Product: PARLODEL
Sponsor: ESJAY PHARMA
Documents: 10
Pages: 104
Coverage: Original approval + 5 supplemental submissions represented