FDA MUCOMYST NDA 013601 Approval Package

This FOIAdocs regulatory document collection brings together historical FDA approval and review records for MUCOMYST (acetylcysteine), NDA 013601. The package contains 2 FDA source files totaling 169 pages, including a 150-page archival FDA regulatory file containing multiple component records and a 19-page supplemental FDA review.

What's included:

• FDA approval and supplemental approval correspondence
• Medical officer reviews
• Clinical review and evaluation
• Pharmacology review
• Statistical review
• Labeling and package-insert materials
• Advisory committee review material
• Clinical-study summaries and data tables
• Related historical FDA records for Mucomyst-Iso, NDA 17-366
• Supplement 29 FDA review
• FOIAdocs document index and detailed source manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 013601
Product: MUCOMYST (acetylcysteine)
Sponsor: APOTHECON
Documents: 2 FDA source files
Pages: 169
Coverage: Historical FDA approval and review records, including supplemental review material and related Mucomyst-Iso / NDA 017366 records