FDA OPDIVO BLA 125554 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for OPDIVO, BLA 125554. The package contains 159 FDA documents totaling 11,067 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
• 77 supplemental submissions represented
• 30 FDA review documents
• 66 approval letters
• 63 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: BLA 125554
Product: OPDIVO
Sponsor: BRISTOL MYERS SQUIBB
Documents: 159
Pages: 11,067
Coverage: Original approval + 77 supplemental submissions represented