{"product_id":"fda-drug-approval-package-proair-hfa-nda-021457","title":"FDA PROAIR HFA NDA 021457 Approval Package — Approval Records \u0026 Labeling","description":"\u003cp\u003eThis FOIAdocs regulatory document collection brings together FDA approval records for PROAIR HFA, NDA 021457. The package contains 15 FDA documents totaling 192 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\u003e7 approval letters\u003c\/li\u003e\n\u003cli\u003e8 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 021457\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e PROAIR HFA\u003cbr\u003e\u003cstrong\u003eSponsor:\u003c\/strong\u003e TEVA BRANDED PHARM\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 15\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 192\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e Original approval + 8 supplemental submissions represented\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51473468719268,"sku":"FDANDA021457","price":169.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-proair-hfa-nda-021457-approval-records.png?v=1788917802","url":"https:\/\/foiadocs.com\/products\/fda-drug-approval-package-proair-hfa-nda-021457","provider":"FOIA Document Source","version":"1.0","type":"link"}