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FDA BIAXIN XL NDA 050775 Approval Package — Approval Records & Labeling

FDA BIAXIN XL NDA 050775 Approval Package — Approval Records & Labeling

$329.00 USD
$329.00 USD
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This FOIAdocs regulatory document collection brings together FDA approval records for BIAXIN XL, NDA 050775. The package contains 39 FDA documents totaling 901 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
  • 22 approval letters
  • 17 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 050775
Product: BIAXIN XL
Sponsor: ABBVIE
Documents: 39
Pages: 901
Coverage: Original approval + 21 supplemental submissions represented
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