{"product_id":"fda-drug-approval-package-lescol-xl-nda-021192","title":"FDA LESCOL XL NDA 021192 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for LESCOL XL, NDA 021192. The package contains 29 FDA documents totaling 455 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\u003e14 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e3 FDA review documents\u003c\/li\u003e\n\u003cli\u003e13 approval letters\u003c\/li\u003e\n\u003cli\u003e13 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 021192\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e LESCOL XL\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e SANDOZ\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 29\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 455\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 14 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471324217508,"sku":"FDANDA021192","price":239.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-lescol-xl-nda-021192-approval-records.png?v=1788833094","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-lescol-xl-nda-021192","provider":"FOIA Document Source","version":"1.0","type":"link"}