{"product_id":"fda-drug-approval-package-biaxin-xl-nda-050775","title":"FDA BIAXIN XL NDA 050775 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for BIAXIN XL, NDA 050775. The package contains 39 FDA documents totaling 901 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\u003e21 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e22 approval letters\u003c\/li\u003e\n\u003cli\u003e17 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 050775\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e BIAXIN XL\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ABBVIE\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 39\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 901\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 21 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51473477796004,"sku":"FDANDA050775","price":329.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-biaxin-xl-nda-050775-approval-records.png?v=1788921183","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-biaxin-xl-nda-050775","provider":"FOIA Document Source","version":"1.0","type":"link"}