FDA ACCUTANE NDA 018662 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ACCUTANE, NDA 018662. The package contains 36 FDA documents totaling 1,218 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
• 20 supplemental submissions represented
• 8 FDA review documents
• 16 approval letters
• 12 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 018662
Product: ACCUTANE
Sponsor: HOFFMANN LA ROCHE
Documents: 36
Pages: 1,218
Coverage: Original approval + 20 supplemental submissions represented