{"answer":{"query":"Scemblix","resolved_as":"applications","packages":5,"applications":["NDA215358"],"identity":{"application_numbers":["NDA215358"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2021-10-29","latest":"2024-04-18","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA215358","date":"2040-05-17","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":"12252479","productNo":"001"},"latest_patent_expiry":"2040-05-17","latest_exclusivity_expiry":"2031-10-29","dated_barriers":31,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":9,"fact_id":"5074cf85a023201546452cd3"}],"label_history":{"events_total":11,"non_cmc_events":9,"counts_by_class":{"LABELING":4,"EFFICACY":5},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA215358","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-22","documents":[{"type":"Letter","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215358Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215358s015lbl.pdf","untrusted":true}}],"fact_id":"25ff3242f2e7d207bb9c23e7"},{"application":"NDA215358","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-11-25","documents":[{"type":"Letter","date":"2025-11-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215358Orig1s012ltr.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215358Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-11-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215358s012lbl.pdf","untrusted":true}}],"fact_id":"b8b80a256b28622feb2b3d21"},{"application":"NDA215358","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-10-02","documents":[{"type":"Label","date":"2025-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215358s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215358Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"465d61bf65b1a145018b2048"},{"application":"NDA215358","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-10-29","documents":[{"type":"Letter","date":"2024-10-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215358Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-10-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358s009lbl.pdf","untrusted":true}}],"fact_id":"d3004446523b8a608b6f2325"},{"application":"NDA215358","submission_no":8,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-10-29","documents":[{"type":"Label","date":"2024-10-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-10-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215358Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"bcb4ceae40a3152f549e1206"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"meaning":"raw FDA codes; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}