FDA CLARITIN-D 24 HOUR NDA 020470 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CLARITIN-D 24 HOUR, NDA 020470. The package contains 13 FDA documents totaling 112 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
• 9 supplemental submissions represented
• 1 FDA review document
• 8 approval letters
• 4 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 020470
Product: CLARITIN-D 24 HOUR
Sponsor: BAYER HEALTHCARE LLC
Documents: 13
Pages: 112
Coverage: Original approval + 9 supplemental submissions represented