FDA MACRODANTIN NDA 016620 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for MACRODANTIN, NDA 016620. The package contains 25 FDA documents totaling 233 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
• 18 supplemental submissions represented
• 13 FDA review documents
• 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 016620
Product: MACRODANTIN
Sponsor: ALMATICA
Documents: 25
Pages: 233
Coverage: Original approval + 18 supplemental submissions represented