{"product_id":"fda-drug-approval-package-omnipaque-12-nda-018956","title":"FDA OMNIPAQUE 12 NDA 018956 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for OMNIPAQUE 12, NDA 018956. The package contains 25 FDA documents totaling 411 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\u003e1 FDA review document\u003c\/li\u003e\n\u003cli\u003e15 approval letters\u003c\/li\u003e\n\u003cli\u003e9 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 018956\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e OMNIPAQUE 12\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e GE HEALTHCARE\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 25\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 411\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 16 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471363834020,"sku":"FDANDA018956","price":229.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-omnipaque-12-nda-018956-approval-records.png?v=1788836810","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-omnipaque-12-nda-018956","provider":"FOIA Document Source","version":"1.0","type":"link"}