{"product_id":"fda-drug-approval-package-risperdal-consta-nda-021346","title":"FDA RISPERDAL CONSTA NDA 021346 Approval Package — Reviews \u0026 Approval Records","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for RISPERDAL CONSTA, NDA 021346. The package contains 64 FDA documents totaling 2,976 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\u003e33 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e16 FDA review documents\u003c\/li\u003e\n\u003cli\u003e27 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 021346\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e RISPERDAL CONSTA\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e JANSSEN PHARMS\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 64\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 2,976\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 33 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51471123021988,"sku":"FDANDA021346","price":609.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-risperdal-consta-nda-021346-approval-records.png?v=1788814990","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-risperdal-consta-nda-021346","provider":"FOIA Document Source","version":"1.0","type":"link"}