FDA RISPERDAL CONSTA NDA 021346 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for RISPERDAL CONSTA, NDA 021346. The package contains 64 FDA documents totaling 2,976 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
• 33 supplemental submissions represented
• 16 FDA review documents
• 27 approval letters
• 21 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 021346
Product: RISPERDAL CONSTA
Sponsor: JANSSEN PHARMS
Documents: 64
Pages: 2,976
Coverage: Original approval + 33 supplemental submissions represented