{"product_id":"fda-drug-approval-package-keytruda-pembrolizumab-bla-125514","title":"FDA Drug Approval Package, Keytruda (pembrolizumab), BLA 125514 — Original Approval \u0026 Supplements","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for Keytruda (pembrolizumab), BLA 125514, sponsored by Merck Sharp \u0026amp; Dohme. The package contains 233 FDA documents totaling 16,491 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\u003e104 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e33 FDA review documents\u003c\/li\u003e\n\u003cli\u003e99 approval letters\u003c\/li\u003e\n\u003cli\u003e101 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 125514\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Keytruda (pembrolizumab)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Merck Sharp \u0026amp; Dohme\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 233\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 16,491\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 104 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51461169873060,"sku":"FDABLA125514","price":1495.0,"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-keytruda-pembrolizumab-bla-125514","provider":"FOIA Document Source","version":"1.0","type":"link"}