FDA SPRYCEL NDA 021986 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for SPRYCEL, NDA 021986. The package contains 38 FDA documents totaling 1,143 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
• 19 supplemental submissions represented
• 2 FDA review documents
• 19 approval letters
• 17 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 021986
Product: SPRYCEL
Sponsor: BRISTOL MYERS SQUIBB
Documents: 38
Pages: 1,143
Coverage: Original approval + 19 supplemental submissions represented