FDA OFEV NDA 205832 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for OFEV, NDA 205832. The package contains 39 FDA documents totaling 1,687 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
• 12 supplemental submissions represented
• 13 FDA review documents
• 13 approval letters
• 13 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 205832
Product: OFEV
Sponsor: BOEHRINGER INGELHEIM
Documents: 39
Pages: 1,687
Coverage: Original approval + 12 supplemental submissions represented