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FDA NORVIR NDA 020659 Approval Package — Reviews & Approval Records
FDA NORVIR NDA 020659 Approval Package — Reviews & Approval Records
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This FOIAdocs regulatory document collection brings together FDA approval records for NORVIR, NDA 020659. The package contains 66 FDA documents totaling 2,172 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
- 33 supplemental submissions represented
- 3 FDA review documents
- 32 approval letters
- 31 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 020659
Product: NORVIR
Sponsor: ABBVIE
Documents: 66
Pages: 2,172
Coverage: Original approval + 33 supplemental submissions represented
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