{"answer":{"query":"Camzyos","resolved_as":"applications","packages":4,"applications":["NDA214998"],"identity":{"application_numbers":["NDA214998"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE, GELATIN COATED","untrusted":true}],"marketing_start":{"earliest":"2022-04-28","latest":"2022-04-28","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA214998","date":"2036-04-28","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":"RE50050","productNo":"001"},"latest_patent_expiry":"2036-04-28","latest_exclusivity_expiry":"2029-04-28","dated_barriers":20,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":3,"fact_id":"42289961b2759bdbf263771d"}],"label_history":{"events_total":7,"non_cmc_events":7,"counts_by_class":{"EFFICACY":3,"LABELING":1,"REMS":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214998","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-30","documents":[{"type":"Letter","date":"2026-10-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214998Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214998s013lbl.pdf","untrusted":true}}],"fact_id":"d5977d8e936cfa21cab2ac84"},{"application":"NDA214998","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-04-17","documents":[{"type":"Label","date":"2025-04-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214998s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214998Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"dedd6135c2f95e07a39ac3c4"},{"application":"NDA214998","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-30","documents":[{"type":"Letter","date":"2024-05-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214998Orig1s009ltr.pdf","untrusted":true}},{"type":"Letter","date":"2024-05-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214998Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214998s009lbl.pdf","untrusted":true}}],"fact_id":"0cc02c9402cf9a9c940b48cd"},{"application":"NDA214998","submission_no":8,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2023-12-19","documents":[{"type":"Letter","date":"2023-12-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214998Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"40e487023d943845687cfe86"},{"application":"NDA214998","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-06-15","documents":[{"type":"Label","date":"2023-06-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214998s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214998Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"1e53e2d980375fff0f2b4554"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"NOT_PROVIDED":5},"marketing_status_counts":{"Prescription":5},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}