FDA ZOHYDRO ER NDA 202880 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ZOHYDRO ER, NDA 202880. The package contains 30 FDA documents totaling 1,258 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
• 10 supplemental submissions represented
• 10 FDA review documents
• 11 approval letters
• 9 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 202880
Product: ZOHYDRO ER
Sponsor: RECRO GAINESVILLE
Documents: 30
Pages: 1,258
Coverage: Original approval + 10 supplemental submissions represented