{"answer":{"query":"Cabenuva","resolved_as":"applications","packages":3,"applications":["NDA212888"],"identity":{"application_numbers":["NDA212888"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2021-01-21","latest":"2025-01-21","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA212888","date":"2040-10-01","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":"12636285","productNo":"001"},"latest_patent_expiry":"2040-10-01","latest_exclusivity_expiry":"2026-01-21","dated_barriers":22,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":1,"fact_id":"674977572fa05a36613a33cb"}],"label_history":{"events_total":10,"non_cmc_events":10,"counts_by_class":{"LABELING":4,"EFFICACY":6},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212888","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-11-26","documents":[{"type":"Label","date":"2025-11-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212888Orig1s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212888Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"7a815cb0681b33bcdd8d783c"},{"application":"NDA212888","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-11","documents":[{"type":"Letter","date":"2025-04-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212888Orig1s16ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212888s016lbl.pdf","untrusted":true}}],"fact_id":"629bdadc1d05351a64699f9d"},{"application":"NDA212888","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-09-20","documents":[{"type":"Letter","date":"2024-09-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212888Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-09-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212888s015lbl.pdf","untrusted":true}}],"fact_id":"00c0368c831838b0ed2d71da"},{"application":"NDA212888","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-13","documents":[{"type":"Letter","date":"2023-12-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212888Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s011lbl.pdf","untrusted":true}}],"fact_id":"f9364acf68c870108e5ebbfa"},{"application":"NDA212888","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-27","documents":[{"type":"Label","date":"2023-02-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-02-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212888Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"e4c7b18f101b960ff4917225"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"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":"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."}