FDA REMICADE BLA 103772 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for REMICADE, BLA 103772. The package contains 78 FDA documents totaling 2,204 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
• 41 supplemental submissions represented
• 4 FDA review documents
• 38 approval letters
• 36 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 103772
Product: REMICADE
Sponsor: CENTOCOR INC
Documents: 78
Pages: 2,204
Coverage: Original approval + 41 supplemental submissions represented