{"answer":{"query":"Remicade","resolved_as":"applications","packages":2,"applications":["BLA103772"],"identity":{"application_numbers":["BLA103772"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true}],"marketing_start":{"earliest":"1998-08-24","latest":"2021-10-05","packages_with_a_start_date":2}},"label_history":{"events_total":55,"non_cmc_events":55,"counts_by_class":{"LABELING":37,"EFFICACY":16,"S":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA103772","submission_no":5412,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-28","documents":[{"type":"Label","date":"2025-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103772s5412lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/103772Orig1s5412ltr.pdf","untrusted":true}}],"fact_id":"312e5ad76b99c93276b2957b"},{"application":"BLA103772","submission_no":5401,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-10-05","documents":[{"type":"Label","date":"2021-10-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-12-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103772Orig1s5401ltr.pdf","untrusted":true}}],"fact_id":"dece1459cbe075392b1e4aec"},{"application":"BLA103772","submission_no":5394,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-05-14","documents":[{"type":"Label","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf","untrusted":true}}],"fact_id":"06e0b08becbe3a904cbba456"},{"application":"BLA103772","submission_no":5391,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-05-14","documents":[{"type":"Label","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf","untrusted":true}}],"fact_id":"e68e36af5e7475ae45d043c9"},{"application":"BLA103772","submission_no":5389,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-05-14","documents":[{"type":"Label","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103772Orig1s5389,s5391,s5394ltr.pdf","untrusted":true}}],"fact_id":"c60b565dca8cd855d1255a11"}],"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:BLA103772","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":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}