FDA GLUCOTROL XL NDA 020329 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for GLUCOTROL XL, NDA 020329. The package contains 20 FDA documents totaling 246 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
• 11 supplemental submissions represented
• 2 FDA review documents
• 9 approval letters
• 9 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 020329
Product: GLUCOTROL XL
Sponsor: PFIZER
Documents: 20
Pages: 246
Coverage: Original approval + 11 supplemental submissions represented