{"answer":{"query":"Tagrisso","resolved_as":"applications","packages":5,"applications":["NDA208065"],"identity":{"application_numbers":["NDA208065"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2015-11-13","latest":"2026-04-19","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA208065","date":"2042-11-26","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":"12465608","productNo":"002"},"latest_patent_expiry":"2042-11-26","latest_exclusivity_expiry":"2027-12-18","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":3,"fact_id":"4da90fc8d41a8dc0f45e7b4b"}],"label_history":{"events_total":24,"non_cmc_events":23,"counts_by_class":{"LABELING":14,"EFFICACY":9},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA208065","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-14","documents":[{"type":"Letter","date":"2026-09-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208065Orig1s035,036ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208065s035s036lbl.pdf","untrusted":true}}],"fact_id":"605beda99fb3e2ce0e3241ad"},{"application":"NDA208065","submission_no":35,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-14","documents":[{"type":"Letter","date":"2026-09-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208065Orig1s035,036ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208065s035s036lbl.pdf","untrusted":true}}],"fact_id":"d2aa40906eaa5cffaf726b3e"},{"application":"NDA208065","submission_no":33,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-09-25","documents":[{"type":"Letter","date":"2024-09-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-09-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf","untrusted":true}}],"fact_id":"18889bbfb2cf267d37ed29ef"},{"application":"NDA208065","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-29","documents":[{"type":"Letter","date":"2024-04-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-04-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s031lbl.pdf","untrusted":true}}],"fact_id":"eb2560bf7895adcbc51ab0d8"},{"application":"NDA208065","submission_no":30,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-02-16","documents":[{"type":"Label","date":"2024-02-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s030lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-02-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208065Orig1s030ltr.pdf","untrusted":true}}],"fact_id":"4262d8f531a4aec90992ba54"}],"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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Each answer lists the facts it rests on."}