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FDA VOLTAREN-XR NDA 020254 Approval Package — Reviews & Approval Records

FDA VOLTAREN-XR NDA 020254 Approval Package — Reviews & Approval Records

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This FOIAdocs regulatory document collection brings together FDA approval records for VOLTAREN-XR, NDA 020254. The package contains 11 FDA documents totaling 135 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
  • 5 supplemental submissions represented
  • 1 FDA review document
  • 5 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 020254
Product: VOLTAREN-XR
Sponsor: NOVARTIS
Documents: 11
Pages: 135
Coverage: Original approval + 5 supplemental submissions represented

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