{"answer":{"query":"Tepezza","resolved_as":"applications","packages":1,"applications":["BLA761143"],"identity":{"application_numbers":["BLA761143"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2020-01-21","latest":"2020-01-21","packages_with_a_start_date":1}},"label_history":{"events_total":8,"non_cmc_events":8,"counts_by_class":{"LABELING":8},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761143","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-23","documents":[{"type":"Letter","date":"2026-09-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761143Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761143s033lbl.pdf","untrusted":true}}],"fact_id":"6a9416d1dfa6be1ed4383d6c"},{"application":"BLA761143","submission_no":32,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-11-24","documents":[{"type":"Letter","date":"2025-11-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761143Orig1s032ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-11-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761143s032lbl.pdf","untrusted":true}}],"fact_id":"f2ad19941075bd0b89786070"},{"application":"BLA761143","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-09-09","documents":[{"type":"Label","date":"2025-09-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761143s030lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-09-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761143Orig1s030ltr.pdf","untrusted":true}}],"fact_id":"179ab5c58146c05d403469be"},{"application":"BLA761143","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-26","documents":[{"type":"Letter","date":"2025-08-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761143Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761143s031lbl.pdf","untrusted":true}}],"fact_id":"da92addfa9bcbd36bb984a4d"},{"application":"BLA761143","submission_no":23,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-07-17","documents":[{"type":"Letter","date":"2023-07-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761143Orig1s023ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-07-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s023lbl.pdf","untrusted":true}}],"fact_id":"ac737be3fa9e759ba976eef3"}],"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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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":"generic_entry:BLA761143","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"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":"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."}