FDA PRIALT NDA 021060 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PRIALT, NDA 021060. The package contains 9 FDA documents totaling 157 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
• 4 supplemental submissions represented
• 1 FDA review document
• 4 approval letters
• 4 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 021060
Product: PRIALT
Sponsor: ESTEVE
Documents: 9
Pages: 157
Coverage: Original approval + 4 supplemental submissions represented