{"product_id":"fda-drug-approval-package-somatuline-depot-nda-022074","title":"FDA SOMATULINE DEPOT NDA 022074 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for SOMATULINE DEPOT, NDA 022074. The package contains 30 FDA documents totaling 1,130 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\u003e5 FDA review documents\u003c\/li\u003e\n\u003cli\u003e12 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 022074\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e SOMATULINE DEPOT\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e IPSEN PHARMA\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 30\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 1,130\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 14 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471324872868,"sku":"FDANDA022074","price":459.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-somatuline-depot-nda-022074-approval-records.png?v=1788833094","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-somatuline-depot-nda-022074","provider":"FOIA Document Source","version":"1.0","type":"link"}