FDA SINGULAIR NDA 021409 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for SINGULAIR, NDA 021409. The package contains 66 FDA documents totaling 813 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
• 31 supplemental submissions represented
• 2 FDA review documents
• 32 approval letters
• 32 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 021409
Product: SINGULAIR
Sponsor: ORGANON
Documents: 66
Pages: 813
Coverage: Original approval + 31 supplemental submissions represented