{"product_id":"fda-drug-approval-package-epidiolex-cannabidiol-nda-210365","title":"FDA Drug Approval Package, Epidiolex (cannabidiol), NDA 210365 — Original Approval \u0026 Supplements","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for Epidiolex (cannabidiol), NDA 210365, sponsored by Jazz Pharmaceuticals. The package contains 33 FDA documents totaling 1,514 pages, organized by original application and supplemental submission.\u003c\/p\u003e\u003cp\u003eInstead of locating and downloading individual records across the application history, buyers receive a research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.\u003c\/p\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eOriginal FDA approval records\u003c\/li\u003e\n\u003cli\u003e10 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e11 FDA review documents\u003c\/li\u003e\n\u003cli\u003e11 approval letters\u003c\/li\u003e\n\u003cli\u003e11 labeling documents\u003c\/li\u003e\n\u003cli\u003eFOIAdocs document index and detailed manifest\u003c\/li\u003e\n\u003c\/ul\u003e\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\u003cp\u003e\u003cstrong\u003eApplication:\u003c\/strong\u003e NDA 210365\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Epidiolex (cannabidiol)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Jazz Pharmaceuticals\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 33\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,514\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 10 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51461170036900,"sku":"FDANDA210365","price":395.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_approval_package_icon_a3c4df44-8733-4273-a834-e2d469ef9aef.png?v=1788120185","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-epidiolex-cannabidiol-nda-210365","provider":"FOIA Document Source","version":"1.0","type":"link"}