{"product_id":"fda-drug-approval-package-spravato-esketamine-nda-211243","title":"FDA Drug Approval Package, Spravato (esketamine), NDA 211243 — Original Approval \u0026 Supplements","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for Spravato (esketamine), NDA 211243, sponsored by Janssen Pharmaceuticals. The package contains 38 FDA documents totaling 2,098 pages, organized by original application and supplemental submission.\u003c\/p\u003e\u003cp\u003eInstead of locating and downloading individual records across the application history, buyers receive a research-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\u003e17 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e12 FDA review documents\u003c\/li\u003e\n\u003cli\u003e18 approval letters\u003c\/li\u003e\n\u003cli\u003e8 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 211243\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e Spravato (esketamine)\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e Janssen Pharmaceuticals\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 38\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 2,098\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 17 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51461170069668,"sku":"FDANDA211243","price":495.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_approval_package_icon_a3c4df44-8733-4273-a834-e2d469ef9aef.png?v=1788120185","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-spravato-esketamine-nda-211243","provider":"FOIA Document Source","version":"1.0","type":"link"}