{"product_id":"fda-drug-approval-package-motrin-ib-nda-019012","title":"FDA MOTRIN IB NDA 019012 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for MOTRIN IB, NDA 019012. The package contains 20 FDA documents totaling 167 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\u003e2 FDA review documents\u003c\/li\u003e\n\u003cli\u003e11 approval letters\u003c\/li\u003e\n\u003cli\u003e7 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 019012\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e MOTRIN IB\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e KENVUE BRANDS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 20\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 167\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 14 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51470741799076,"sku":"FDANDA019012","price":169.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-motrin-ib-nda-019012-approval-records.png?v=1788744479","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-motrin-ib-nda-019012","provider":"FOIA Document Source","version":"1.0","type":"link"}