{"product_id":"fda-drug-approval-package-adempas-nda-204819","title":"FDA ADEMPAS NDA 204819 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for ADEMPAS, NDA 204819. The package contains 31 FDA documents totaling 1,183 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\u003e13 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e10 FDA review documents\u003c\/li\u003e\n\u003cli\u003e14 approval letters\u003c\/li\u003e\n\u003cli\u003e7 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 204819\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e ADEMPAS\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e BAYER HLTHCARE\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 31\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,183\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 13 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465763520676,"sku":"FDANDA204819","price":469.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-adempas-nda-204819-approval-records.png?v=1788570415","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-adempas-nda-204819","provider":"FOIA Document Source","version":"1.0","type":"link"}