{"product_id":"fda-drug-approval-package-dupixent-dupilumab-bla-761055","title":"FDA Drug Approval Package, Dupixent (dupilumab), BLA 761055 — Original Approval \u0026 Supplements","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for Dupixent (dupilumab), BLA 761055, sponsored by Regeneron Pharmaceuticals. The package contains 72 FDA documents totaling 3,928 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\u003e29 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e15 FDA review documents\u003c\/li\u003e\n\u003cli\u003e28 approval letters\u003c\/li\u003e\n\u003cli\u003e29 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 BLA 761055\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Dupixent (dupilumab)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Regeneron Pharmaceuticals\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 72\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 3,928\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 29 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51461169938596,"sku":"FDABLA761055","price":695.0,"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-dupixent-dupilumab-bla-761055","provider":"FOIA Document Source","version":"1.0","type":"link"}