{"product_id":"fda-drug-approval-package-glucophage-xr-nda-021202","title":"FDA GLUCOPHAGE XR NDA 021202 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for GLUCOPHAGE XR, NDA 021202. The package contains 15 FDA documents totaling 218 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\u003e8 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e9 approval letters\u003c\/li\u003e\n\u003cli\u003e6 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 021202\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e GLUCOPHAGE XR\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e EMD SERONO INC\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 15\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 218\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 8 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51473468457124,"sku":"FDANDA021202","price":169.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-glucophage-xr-nda-021202-approval-records.png?v=1788917802","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-glucophage-xr-nda-021202","provider":"FOIA Document Source","version":"1.0","type":"link"}