FDA STELARA BLA 125261 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for STELARA, BLA 125261. The package contains 61 FDA documents totaling 1,659 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
• 31 supplemental submissions represented
• 3 FDA review documents
• 31 approval letters
• 27 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 125261
Product: STELARA
Sponsor: CENTOCOR ORTHO BIOTECH INC
Documents: 61
Pages: 1,659
Coverage: Original approval + 31 supplemental submissions represented