{"product_id":"fda-drug-approval-package-duragesic-100-nda-019813","title":"FDA DURAGESIC-100 NDA 019813 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for DURAGESIC-100, NDA 019813. The package contains 45 FDA documents totaling 2,167 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\u003e29 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e13 FDA review documents\u003c\/li\u003e\n\u003cli\u003e20 approval letters\u003c\/li\u003e\n\u003cli\u003e12 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 019813\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e DURAGESIC-100\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e JANSSEN PHARMS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 45\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 2,167\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 29 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51474394513572,"sku":"FDANDA019813","price":599.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-duragesic-100-nda-019813-approval-records.png?v=1789006297","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-duragesic-100-nda-019813","provider":"FOIA Document Source","version":"1.0","type":"link"}