{"product_id":"fda-drug-approval-package-opana-er-nda-021610","title":"FDA OPANA ER NDA 021610 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for OPANA ER, NDA 021610. The package contains 34 FDA documents totaling 546 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\u003e21 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e20 approval letters\u003c\/li\u003e\n\u003cli\u003e14 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 021610\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e OPANA ER\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ENDO OPERATIONS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 34\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 546\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 21 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465762832548,"sku":"FDANDA021610","price":329.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-opana-er-nda-021610-approval-records.png?v=1788570415","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-opana-er-nda-021610","provider":"FOIA Document Source","version":"1.0","type":"link"}