FDA ADVAIR DISKUS 100/50 NDA 021077 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ADVAIR DISKUS 100/50, NDA 021077. The package contains 45 FDA documents totaling 2,418 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
• 24 supplemental submissions represented
• 9 FDA review documents
• 21 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 021077
Product: ADVAIR DISKUS 100/50
Sponsor: GLAXO GRP LTD
Documents: 45
Pages: 2,418
Coverage: Original approval + 24 supplemental submissions represented