{"product_id":"fda-drug-approval-package-prograf-nda-050709","title":"FDA PROGRAF NDA 050709 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for PROGRAF, NDA 050709. The package contains 37 FDA documents totaling 1,195 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\u003e20 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e2 FDA review documents\u003c\/li\u003e\n\u003cli\u003e17 approval letters\u003c\/li\u003e\n\u003cli\u003e18 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 NDA 050709\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e PROGRAF\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ASTELLAS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 37\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,195\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 20 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471325200548,"sku":"FDANDA050709","price":449.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-prograf-nda-050709-approval-records.png?v=1788833093","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-prograf-nda-050709","provider":"FOIA Document Source","version":"1.0","type":"link"}