{"product_id":"fda-drug-approval-package-entocort-ec-nda-021324","title":"FDA ENTOCORT EC NDA 021324 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for ENTOCORT EC, NDA 021324. The package contains 24 FDA documents totaling 417 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\u003e11 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e2 FDA review documents\u003c\/li\u003e\n\u003cli\u003e12 approval letters\u003c\/li\u003e\n\u003cli\u003e10 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 021324\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e ENTOCORT EC\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e PADAGIS US\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 24\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 417\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 11 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471324250276,"sku":"FDANDA021324","price":229.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-entocort-ec-nda-021324-approval-records.png?v=1788833094","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-entocort-ec-nda-021324","provider":"FOIA Document Source","version":"1.0","type":"link"}