FDA OPANA ER NDA 021610 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for OPANA ER, NDA 021610. The package contains 34 FDA documents totaling 546 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
• 21 supplemental submissions represented
• 20 approval letters
• 14 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 021610
Product: OPANA ER
Sponsor: ENDO OPERATIONS
Documents: 34
Pages: 546
Coverage: Original approval + 21 supplemental submissions represented