{"product_id":"fda-drug-approval-package-prolia-bla-125320","title":"FDA PROLIA BLA 125320 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for PROLIA, BLA 125320. The package contains 95 FDA documents totaling 4,869 pages, organized by original application and supplemental submission.\u003c\/p\u003e\u003cp\u003eResearch-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\u003e47 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e5 FDA review documents\u003c\/li\u003e\n\u003cli\u003e47 approval letters\u003c\/li\u003e\n\u003cli\u003e43 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 125320\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e PROLIA\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e AMGEN\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 95\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 4,869\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 47 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465762144420,"sku":"FDABLA125320","price":739.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-prolia-bla-125320-approval-records.png?v=1788570415","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-prolia-bla-125320","provider":"FOIA Document Source","version":"1.0","type":"link"}