{"product_id":"fda-drug-approval-package-mounjaro-tirzepatide-nda-215866","title":"FDA Drug Approval Package, Mounjaro (tirzepatide), NDA 215866 — Original Approval \u0026 Supplements","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for Mounjaro (tirzepatide), NDA 215866, sponsored by Eli Lilly and Company. The package contains 28 FDA documents totaling 1,504 pages, organized by original application and supplemental submission.\u003c\/p\u003e\n\u003cp\u003eResearch-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.\u003c\/p\u003e\n\u003ch3\u003eWhat's included\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eOriginal FDA approval records\u003c\/li\u003e\n\u003cli\u003e8 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e11 FDA review documents\u003c\/li\u003e\n\u003cli\u003e9 approval letters\u003c\/li\u003e\n\u003cli\u003e8 labeling documents\u003c\/li\u003e\n\u003cli\u003eFOIAdocs document index and detailed 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\u003cstrong\u003eApplication:\u003c\/strong\u003e NDA 215866\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Mounjaro (tirzepatide)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Eli Lilly and Company\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 28\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,504\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 8 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51461170135204,"sku":"FDANDA215866","price":495.0,"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-mounjaro-tirzepatide-nda-215866","provider":"FOIA Document Source","version":"1.0","type":"link"}