FDA FLONASE NDA 020121 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for FLONASE, NDA 020121. The package contains 13 FDA documents totaling 296 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
• 1 FDA review document
• 7 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 020121
Product: FLONASE
Sponsor: HALEON US HOLDINGS
Documents: 13
Pages: 296
Coverage: Original approval + 8 supplemental submissions represented