{"product_id":"fda-drug-approval-package-prilosec-otc-nda-021229","title":"FDA PRILOSEC OTC NDA 021229 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for PRILOSEC OTC, NDA 021229. The package contains 36 FDA documents totaling 189 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\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 021229\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e PRILOSEC OTC\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ASTRAZENECA\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 36\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 189\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 22 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465762603172,"sku":"FDANDA021229","price":169.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-prilosec-otc-nda-021229-approval-records.png?v=1788570415","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-prilosec-otc-nda-021229","provider":"FOIA Document Source","version":"1.0","type":"link"}