{"product_id":"fda-drug-approval-package-depakote-er-nda-021168","title":"FDA DEPAKOTE ER NDA 021168 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for DEPAKOTE ER, NDA 021168. The package contains 70 FDA documents totaling 2,351 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\u003e35 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e35 approval letters\u003c\/li\u003e\n\u003cli\u003e35 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 021168\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e DEPAKOTE ER\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ABBVIE\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 70\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 2,351\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 35 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471324151972,"sku":"FDANDA021168","price":579.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-depakote-er-nda-021168-approval-records.png?v=1788833094","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-depakote-er-nda-021168","provider":"FOIA Document Source","version":"1.0","type":"link"}