FDA ORTHO CYCLEN-21 NDA 019653 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ORTHO CYCLEN-21, NDA 019653. The package contains 28 FDA documents totaling 557 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
• 23 supplemental submissions represented
• 14 FDA review documents
• 9 approval letters
• 5 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 019653
Product: ORTHO CYCLEN-21
Sponsor: JANSSEN PHARMS
Documents: 28
Pages: 557
Coverage: Original approval + 23 supplemental submissions represented