{"answer":{"query":"Auryxia","resolved_as":"applications","packages":2,"applications":["NDA205874"],"identity":{"application_numbers":["NDA205874"],"marketing_categories":["NDA AUTHORIZED GENERIC","NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2014-09-17","latest":"2025-03-20","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA205874","date":"2030-07-21","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"10300039","productNo":"001"},"latest_patent_expiry":"2030-07-21","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"98554b96a130c4a41e00c70b"}],"label_history":{"events_total":13,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":8,"recent_non_cmc_events":[{"application":"NDA205874","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-19","documents":[{"type":"Label","date":"2024-01-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205874s029lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-01-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205874Orig1s029ltr.pdf","untrusted":true}}],"fact_id":"c3d99e8f9aae889cbfa363b2"},{"application":"NDA205874","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-10","documents":[{"type":"Label","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205874s027lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205874Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"5b9b0de8f65d9af1c9c939b2"},{"application":"NDA205874","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2017-11-06","documents":[{"type":"Label","date":"2017-11-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205874s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-11-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205874Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"91135b2467b24617234064c3"},{"application":"NDA205874","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-07-21","documents":[{"type":"Label","date":"2015-07-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2015-07-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205874Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"92fe57cd08b5de19ce17e772"},{"application":"NDA205874","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2014-11-15","documents":[{"type":"Label","date":"2014-11-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2014-11-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"f1a4223467f36f658ba75cd2"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"AB":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}