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FDA AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDA 021277 Approval Package — Reviews & Approval Records

FDA AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDA 021277 Approval Package — Reviews & Approval Records

$449.00 USD
$449.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, NDA 021277. The package contains 67 FDA documents totaling 1,460 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
  • 34 supplemental submissions represented
  • 2 FDA review documents
  • 34 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 021277
Product: AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor: BAYER HLTHCARE
Documents: 67
Pages: 1,460
Coverage: Original approval + 34 supplemental submissions represented
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