FDA PRILOSEC NDA 019810 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PRILOSEC, NDA 019810. The package contains 51 FDA documents totaling 1,518 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
• 28 supplemental submissions represented
• 5 FDA review documents
• 24 approval letters
• 22 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 019810
Product: PRILOSEC
Sponsor: ASTRAZENECA
Documents: 51
Pages: 1,518
Coverage: Original approval + 28 supplemental submissions represented