FDA CETROTIDE NDA 021197 Approval Package — Approval Records & Labeling

This FOIAdocs regulatory document collection brings together FDA approval records for CETROTIDE, NDA 021197. The package contains 13 FDA documents totaling 95 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
• 7 supplemental submissions represented
• 8 approval letters
• 5 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 021197
Product: CETROTIDE
Sponsor: EMD SERONO INC
Documents: 13
Pages: 95
Coverage: Original approval + 7 supplemental submissions represented