{"answer":{"query":"Rezurock","resolved_as":"applications","packages":1,"applications":["NDA214783"],"identity":{"application_numbers":["NDA214783"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2021-07-16","latest":"2021-07-16","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA214783","date":"2042-07-14","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":"12097202","productNo":"001"},"latest_patent_expiry":"2042-07-14","latest_exclusivity_expiry":"2028-07-16","dated_barriers":7,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":2,"fact_id":"2dc23fb8d93eaf6c96964fc4"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214783","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-15","documents":[{"type":"Label","date":"2026-01-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214783s012lbl.pdf","untrusted":true}}],"fact_id":"6b543c2dd95ee86e1fa05ca9"},{"application":"NDA214783","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-30","documents":[{"type":"Label","date":"2025-01-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214783s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214783Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"c693905c62dadb9c5edb424b"},{"application":"NDA214783","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-10","documents":[{"type":"Label","date":"2024-04-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214783s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-04-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214783Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"cb6e9b738c1d5d965b018603"},{"application":"NDA214783","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-09","documents":[{"type":"Label","date":"2023-11-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214783s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-11-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214783Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"784f756c39a29cb5d1c539c8"}],"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."}