FDA ABRAXANE NDA 021660 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ABRAXANE, NDA 021660. The package contains 38 FDA documents totaling 1,362 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
• 16 supplemental submissions represented
• 8 FDA review documents
• 15 approval letters
• 15 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 021660
Product: ABRAXANE
Sponsor: BRISTOL-MYERS
Documents: 38
Pages: 1,362
Coverage: Original approval + 16 supplemental submissions represented