FDA INTELENCE NDA 022187 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for INTELENCE, NDA 022187. The package contains 28 FDA documents totaling 552 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
• 13 supplemental submissions represented
• 1 FDA review document
• 13 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 022187
Product: INTELENCE
Sponsor: JANSSEN R AND D
Documents: 28
Pages: 552
Coverage: Original approval + 13 supplemental submissions represented