FDA PROPULSID NDA 020210 Approval Package — FDA Reviews

This FOIAdocs regulatory document collection brings together FDA approval records for PROPULSID, NDA 020210. The package contains 2 FDA documents totaling 97 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
• 2 FDA review 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 020210
Product: PROPULSID
Sponsor: JANSSEN PHARMS
Documents: 2
Pages: 97
Coverage: Original approval + 2 supplemental submissions represented