{"product_id":"fda-drug-approval-package-lamictal-cd-nda-020764","title":"FDA LAMICTAL CD NDA 020764 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for LAMICTAL CD, NDA 020764. The package contains 53 FDA documents totaling 2,415 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\u003e28 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e2 FDA review documents\u003c\/li\u003e\n\u003cli\u003e25 approval letters\u003c\/li\u003e\n\u003cli\u003e26 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 020764\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e LAMICTAL CD\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e GLAXOSMITHKLINE LLC\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 53\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 2,415\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 28 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51470757953700,"sku":"FDANDA020764","price":579.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-lamictal-cd-nda-020764-approval-records.png?v=1788748107","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-lamictal-cd-nda-020764","provider":"FOIA Document Source","version":"1.0","type":"link"}