{"product_id":"fda-drug-approval-package-children-s-claritin-nda-021891","title":"FDA CHILDREN'S CLARITIN NDA 021891 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for CHILDREN'S CLARITIN, NDA 021891. The package contains 44 FDA documents totaling 249 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\u003e22 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e23 approval letters\u003c\/li\u003e\n\u003cli\u003e21 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 021891\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e CHILDREN'S CLARITIN\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e BAYER HEALTHCARE LLC\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 44\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 249\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 22 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51474395693220,"sku":"FDANDA021891","price":169.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-children-s-claritin-nda-021891-approval-records.png?v=1789006297","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-children-s-claritin-nda-021891","provider":"FOIA Document Source","version":"1.0","type":"link"}