FDA PROZAC NDA 018936 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PROZAC, NDA 018936. The package contains 60 FDA documents totaling 1,338 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
• 35 supplemental submissions represented
• 7 FDA review documents
• 28 approval letters
• 25 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 018936
Product: PROZAC
Sponsor: ELI LILLY AND CO
Documents: 60
Pages: 1,338
Coverage: Original approval + 35 supplemental submissions represented