FDA CLARITIN NDA 019658 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CLARITIN, NDA 019658. The package contains 26 FDA documents totaling 198 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
• 16 supplemental submissions represented
• 1 FDA review document
• 13 approval letters
• 12 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 019658
Product: CLARITIN
Sponsor: BAYER HEALTHCARE LLC
Documents: 26
Pages: 198
Coverage: Original approval + 16 supplemental submissions represented