{"product_id":"fda-drug-approval-package-simponi-aria-bla-125433","title":"FDA SIMPONI ARIA BLA 125433 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for SIMPONI ARIA, BLA 125433. The package contains 33 FDA documents totaling 1,329 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\u003e16 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e2 FDA review documents\u003c\/li\u003e\n\u003cli\u003e16 approval letters\u003c\/li\u003e\n\u003cli\u003e15 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 125433\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e SIMPONI ARIA\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e JANSSEN BIOTECH\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 33\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,329\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 16 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471121318052,"sku":"FDABLA125433","price":449.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-simponi-aria-bla-125433-approval-records.png?v=1788814990","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-simponi-aria-bla-125433","provider":"FOIA Document Source","version":"1.0","type":"link"}