{"product_id":"fda-drug-approval-package-mucomyst-nda-013601","title":"FDA MUCOMYST NDA 013601 Approval Package","description":"\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003eThis 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.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat's included\u003c\/strong\u003e:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eFDA approval and supplemental approval correspondence\u003c\/li\u003e\n\u003cli\u003eMedical officer reviews\u003c\/li\u003e\n\u003cli\u003eClinical review and evaluation\u003c\/li\u003e\n\u003cli\u003ePharmacology review\u003c\/li\u003e\n\u003cli\u003eStatistical review\u003c\/li\u003e\n\u003cli\u003eLabeling and package-insert materials\u003c\/li\u003e\n\u003cli\u003eAdvisory committee review material\u003c\/li\u003e\n\u003cli\u003eClinical-study summaries and data tables\u003c\/li\u003e\n\u003cli\u003eRelated historical FDA records for Mucomyst-Iso, NDA 17-366\u003c\/li\u003e\n\u003cli\u003eSupplement 29 FDA review\u003c\/li\u003e\n\u003cli\u003eFOIAdocs document index and detailed source manifest\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003ePackage format:\u003c\/strong\u003e Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cstrong\u003eApplication:\u003c\/strong\u003e NDA 013601\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e MUCOMYST (acetylcysteine)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e APOTHECON\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 2 FDA source files\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 169\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Historical FDA approval and review records, including supplemental review material and related Mucomyst-Iso \/ NDA 017366 records\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465762177188,"sku":"FDANDA013601","price":589.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/Screenshot2026-09-06at6.56.25AM.png?v=1788634747","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-mucomyst-nda-013601","provider":"FOIA Document Source","version":"1.0","type":"link"}