FDA AZELEX NDA 020428 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for AZELEX, NDA 020428. The package contains 7 FDA documents totaling 321 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
• 5 supplemental submissions represented
• 2 FDA review documents
• 2 approval letters
• 3 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 020428
Product: AZELEX
Sponsor: ALMIRALL
Documents: 7
Pages: 321
Coverage: Original approval + 5 supplemental submissions represented