{"answer":{"query":"Belsomra","resolved_as":"applications","packages":8,"applications":["NDA204569"],"identity":{"application_numbers":["NDA204569"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2014-08-29","latest":"2014-08-29","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA204569","date":"2033-05-29","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":"10098892","productNo":"003"},"latest_patent_expiry":"2033-05-29","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"e1719414bc24e5e35bc2b6f0"}],"label_history":{"events_total":9,"non_cmc_events":7,"counts_by_class":{"LABELING":6,"EFFICACY":1},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA204569","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-10","documents":[{"type":"Label","date":"2025-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204569s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204569Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"47a707f05e02a20630e41409"},{"application":"NDA204569","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-25","documents":[{"type":"Label","date":"2021-03-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-03-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204569Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"df104bb03be1a6d62bae5330"},{"application":"NDA204569","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-03-18","documents":[{"type":"Label","date":"2020-03-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"2bda2b2053963a8fad564d79"},{"application":"NDA204569","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-01-29","documents":[{"type":"Letter","date":"2020-02-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204569Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-01-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf","untrusted":true}}],"fact_id":"8acfebf5385865bb7de98a17"},{"application":"NDA204569","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-07-12","documents":[{"type":"Label","date":"2018-07-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-07-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204569Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"d121914e1a0fa4be06542b1b"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":4},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}