{"product_id":"fda-drug-approval-package-augmentin-xr-nda-050785","title":"FDA AUGMENTIN XR NDA 050785 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for AUGMENTIN XR, NDA 050785. The package contains 27 FDA documents totaling 259 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\u003e16 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e16 approval letters\u003c\/li\u003e\n\u003cli\u003e11 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 050785\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e AUGMENTIN XR\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e US ANTIBIOTICS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 27\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 259\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 16 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51474437177508,"sku":"FDANDA050785","price":229.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-augmentin-xr-nda-050785-approval-records.png?v=1789009497","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-augmentin-xr-nda-050785","provider":"FOIA Document Source","version":"1.0","type":"link"}