FDA PENNSAID NDA 020947 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for PENNSAID, NDA 020947. The package contains 10 FDA documents totaling 167 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
• 5 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 020947
Product: PENNSAID
Sponsor: NUVO PHARMS INC
Documents: 10
Pages: 167
Coverage: Original approval + 4 supplemental submissions represented