FDA PRECOSE NDA 020482 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PRECOSE, NDA 020482. The package contains 15 FDA documents totaling 410 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
• 8 supplemental submissions represented
• 2 FDA review documents
• 8 approval letters
• 5 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 020482
Product: PRECOSE
Sponsor: BAYER HLTHCARE
Documents: 15
Pages: 410
Coverage: Original approval + 8 supplemental submissions represented