{"answer":{"query":"Lumakras","resolved_as":"applications","packages":5,"applications":["NDA214665"],"identity":{"application_numbers":["NDA214665"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, COATED","untrusted":true}],"marketing_start":{"earliest":"2021-05-28","latest":"2024-06-27","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA214665","date":"2040-09-15","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":"11426404","productNo":"002"},"latest_patent_expiry":"2040-09-15","latest_exclusivity_expiry":"2032-01-16","dated_barriers":30,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":5,"fact_id":"083fb28e9fdceb7ab0ec35d9"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"EFFICACY":1,"LABELING":5},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214665","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-01-16","documents":[{"type":"Label","date":"2025-02-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214665Orig1s009correctedlbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214665Orig1s009correctedltr.pdf","untrusted":true}}],"fact_id":"5b8a4391287bfded4bd4fc76"},{"application":"NDA214665","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-09-30","documents":[{"type":"Letter","date":"2024-10-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214665Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-10-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf","untrusted":true}}],"fact_id":"d39cf2cb6bc4644e25e30ccf"},{"application":"NDA214665","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-04-24","documents":[{"type":"Label","date":"2023-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-04-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"27ec0f7fbd70443568e66ec0"},{"application":"NDA214665","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-17","documents":[{"type":"Letter","date":"2023-03-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"53c687f84842a57db661105a"},{"application":"NDA214665","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-01-20","documents":[{"type":"Label","date":"2023-01-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-01-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"fd6addbef7ece2b87dee6707"}],"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."}