FDA CLARITIN-D NDA 019670 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for CLARITIN-D, NDA 019670. The package contains 12 FDA documents totaling 113 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
• 1 FDA review document
• 7 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 019670
Product: CLARITIN-D
Sponsor: BAYER HEALTHCARE LLC
Documents: 12
Pages: 113
Coverage: Original approval + 7 supplemental submissions represented