FDA PRILOSEC OTC NDA 021229 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for PRILOSEC OTC, NDA 021229. The package contains 36 FDA documents totaling 189 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
• 22 supplemental submissions represented
• 23 approval letters
• 13 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 021229
Product: PRILOSEC OTC
Sponsor: ASTRAZENECA
Documents: 36
Pages: 189
Coverage: Original approval + 22 supplemental submissions represented