{"product_id":"fda-drug-approval-package-asmanex-twisthaler-nda-021067","title":"FDA ASMANEX TWISTHALER NDA 021067 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for ASMANEX TWISTHALER, NDA 021067. The package contains 13 FDA documents totaling 158 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\u003e6 supplemental submissions represented\u003c\/li\u003e\n\u003cli\u003e7 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 021067\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e ASMANEX TWISTHALER\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e ORGANON LLC\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 13\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 158\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 6 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51473477173412,"sku":"FDANDA021067","price":169.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-asmanex-twisthaler-nda-021067","provider":"FOIA Document Source","version":"1.0","type":"link"}