FDA GENOTROPIN BLA 020280 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for GENOTROPIN, BLA 020280. The package contains 43 FDA documents totaling 692 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
• 23 supplemental submissions represented
• 3 FDA review documents
• 22 approval letters
• 18 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 020280
Product: GENOTROPIN
Sponsor: PHARMACIA
Documents: 43
Pages: 692
Coverage: Original approval + 23 supplemental submissions represented