{"answer":{"query":"Xigduo XR","resolved_as":"applications","packages":9,"applications":["NDA205649"],"identity":{"application_numbers":["NDA205649"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED, EXTENDED RELEASE","untrusted":true}],"marketing_start":{"earliest":"2014-11-11","latest":"2024-01-03","packages_with_a_start_date":9}},"generic_entry":[{"application":"NDA205649","date":"2031-05-12","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":"9616028*PED","productNo":"001"},"latest_patent_expiry":"2031-05-12","latest_exclusivity_expiry":"2027-12-12","dated_barriers":60,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":2,"fact_id":"dd143b76457bdb5b0f2f9886"}],"label_history":{"events_total":22,"non_cmc_events":17,"counts_by_class":{"LABELING":11,"EFFICACY":6},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA205649","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-11","documents":[{"type":"Letter","date":"2026-08-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205649Orig1s028,s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205649s028s029lbl.pdf","untrusted":true}}],"fact_id":"06a6561a80014d17358c91de"},{"application":"NDA205649","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-11","documents":[{"type":"Letter","date":"2026-08-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205649Orig1s028,s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205649s028s029lbl.pdf","untrusted":true}}],"fact_id":"69f7dd0f13907e439b719381"},{"application":"NDA205649","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-12-20","documents":[{"type":"Label","date":"2024-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205649s023lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205649Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"1f1413efd1bbeff6b9d392a5"},{"application":"NDA205649","submission_no":22,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-06-12","documents":[{"type":"Letter","date":"2024-06-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202293Orig1s031,205649Orig1s022ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205649s022lbl.pdf","untrusted":true}}],"fact_id":"c63f4d5d343c7640f4fa1eff"},{"application":"NDA205649","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-12","documents":[{"type":"Letter","date":"2023-09-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s030;205649Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-09-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf","untrusted":true}}],"fact_id":"f7bd6c6acfbf88ec9e253a84"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"AB":5},"marketing_status_counts":{"Prescription":5},"meaning":"raw FDA codes; 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Offers change and expire; read each offer's source and stated end date. 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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":"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."}