FDA CLIMARA NDA 020375 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CLIMARA, NDA 020375. The package contains 30 FDA documents totaling 492 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
• 17 supplemental submissions represented
• 1 FDA review document
• 15 approval letters
• 14 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 020375
Product: CLIMARA
Sponsor: BAYER HLTHCARE
Documents: 30
Pages: 492
Coverage: Original approval + 17 supplemental submissions represented