{"product_id":"fda-drug-approval-package-nucynta-er-nda-200533","title":"FDA NUCYNTA ER NDA 200533 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for NUCYNTA ER, NDA 200533. The package contains 40 FDA documents totaling 1,415 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\u003e18 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e10 FDA review documents\u003c\/li\u003e\n\u003cli\u003e19 approval letters\u003c\/li\u003e\n\u003cli\u003e11 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 200533\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e NUCYNTA ER\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e COLLEGIUM PHARM INC\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 40\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,415\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 18 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465763455140,"sku":"FDANDA200533","price":469.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-nucynta-er-nda-200533-approval-records.png?v=1788570415","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-nucynta-er-nda-200533","provider":"FOIA Document Source","version":"1.0","type":"link"}