{"answer":{"query":"Tibsovo","resolved_as":"applications","packages":1,"applications":["NDA211192"],"identity":{"application_numbers":["NDA211192"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2021-10-19","latest":"2021-10-19","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA211192","date":"2039-06-07","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":"10980788","productNo":"001"},"latest_patent_expiry":"2039-06-07","latest_exclusivity_expiry":"2030-10-24","dated_barriers":14,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":4,"fact_id":"44a3d882937531385beff455"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"EFFICACY":4,"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA211192","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-10-24","documents":[{"type":"Label","date":"2023-10-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-10-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211192Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"c418f9dd8c0764e29e50a8be"},{"application":"NDA211192","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-05-25","documents":[{"type":"Label","date":"2022-05-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-05-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211192Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"71aacd8de4e49fe609dd84b9"},{"application":"NDA211192","submission_no":8,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-08-25","documents":[{"type":"Label","date":"2021-08-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-08-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211192Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"903ca87c94210d62127c0c1b"},{"application":"NDA211192","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-18","documents":[{"type":"Letter","date":"2021-03-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211192Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"63f2f704f4e8b596f05bef15"},{"application":"NDA211192","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-03-17","documents":[{"type":"Letter","date":"2020-03-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211192Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"fb3cb561dc539c1706fa719b"}],"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":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}