{"answer":{"query":"Cabometyx","resolved_as":"applications","packages":13,"applications":["NDA208692"],"identity":{"application_numbers":["NDA208692"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2016-04-25","latest":"2023-01-09","packages_with_a_start_date":13}},"generic_entry":[{"application":"NDA208692","date":"2033-07-09","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":"9724342","productNo":"001"},"latest_patent_expiry":"2033-07-09","latest_exclusivity_expiry":"2032-03-26","dated_barriers":39,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":3,"fact_id":"70740b46768cb322d725cae9"}],"label_history":{"events_total":14,"non_cmc_events":13,"counts_by_class":{"LABELING":6,"EFFICACY":7},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA208692","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-09","documents":[{"type":"Label","date":"2025-10-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208692s019lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208692Orig1s019ltr.pdf","untrusted":true}}],"fact_id":"02a292cf399a60491806d0d8"},{"application":"NDA208692","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-09-10","documents":[{"type":"Letter","date":"2025-09-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208692Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-09-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208692s018lbl.pdf","untrusted":true}}],"fact_id":"1c16ba84c9e814604b5b277e"},{"application":"NDA208692","submission_no":17,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-03-26","documents":[{"type":"Label","date":"2025-03-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208692s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208692Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"3f2f38e159cd9c8116d69474"},{"application":"NDA208692","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-20","documents":[{"type":"Letter","date":"2023-09-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208692Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-09-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208692s016lbl.pdf","untrusted":true}}],"fact_id":"a562972e32922c63d12aea8a"},{"application":"NDA208692","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-13","documents":[{"type":"Letter","date":"2023-02-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208692Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf","untrusted":true}}],"fact_id":"d4cea97e13f63d62aa049388"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AB":3},"marketing_status_counts":{"Prescription":3},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}