{"product_id":"fda-drug-approval-package-fabrazyme-bla-103979","title":"FDA FABRAZYME BLA 103979 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for FABRAZYME, BLA 103979. The package contains 16 FDA documents totaling 401 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\u003e8 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e1 FDA review document\u003c\/li\u003e\n\u003cli\u003e7 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\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 103979\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e FABRAZYME\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e GENZYME\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 16\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 401\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 8 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51474394316964,"sku":"FDABLA103979","price":229.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-fabrazyme-bla-103979-approval-records.png?v=1789006297","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-fabrazyme-bla-103979","provider":"FOIA Document Source","version":"1.0","type":"link"}