{"answer":{"query":"Botox","resolved_as":"applications","packages":10,"applications":["BLA103000"],"identity":{"application_numbers":["BLA103000"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true}],"marketing_start":{"earliest":"1989-12-15","latest":"2026-02-03","packages_with_a_start_date":10}},"label_history":{"events_total":59,"non_cmc_events":59,"counts_by_class":{"EFFICACY":24,"LABELING":20,"S":15},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA103000","submission_no":5331,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Label","date":"2024-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103000Orig1s5331,5319,5316,5323,5326ltr.pdf","untrusted":true}}],"fact_id":"4bae21a883fc49ab9fbc45ae"},{"application":"BLA103000","submission_no":5326,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Letter","date":"2024-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103000Orig1s5331,5319,5316,5323,5326ltr.pdf","untrusted":true}}],"fact_id":"d56b3b00dcbd5f69d9d77d1e"},{"application":"BLA103000","submission_no":5323,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Label","date":"2024-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103000Orig1s5331,5319,5316,5323,5326ltr.pdf","untrusted":true}}],"fact_id":"95cf05abd538941c24f0b078"},{"application":"BLA103000","submission_no":5319,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Label","date":"2024-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103000Orig1s5331,5319,5316,5323,5326ltr.pdf","untrusted":true}}],"fact_id":"d0887b40f4801908042e4efd"},{"application":"BLA103000","submission_no":5316,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Label","date":"2024-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103000Orig1s5331,5319,5316,5323,5326ltr.pdf","untrusted":true}}],"fact_id":"b6582e89383f1158ef2faa34"}],"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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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:BLA103000","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":"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":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is 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."}