{"answer":{"query":"Humulin R","resolved_as":"applications","packages":4,"applications":["BLA018780"],"identity":{"application_numbers":["BLA018780"],"marketing_categories":["BLA"],"labelers":[{"text":"ELI LILLY AND COMPANY","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"1983-06-27","latest":"2023-06-20","packages_with_a_start_date":4}},"label_history":{"events_total":101,"non_cmc_events":38,"counts_by_class":{"LABELING":36,"EFFICACY":2},"cmc_events":63,"recent_non_cmc_events":[{"application":"BLA018780","submission_no":180,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-27","documents":[{"type":"Letter","date":"2022-06-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018780Orig1s180ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf","untrusted":true}}],"fact_id":"2d6d47e596dbb7e01763eb49"},{"application":"BLA018780","submission_no":176,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s175, s176ltr.pdf","untrusted":true}}],"fact_id":"f17a949d12e51c6a04737163"},{"application":"BLA018780","submission_no":175,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s175, s176ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-08-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf","untrusted":true}}],"fact_id":"a8f57f2c3bd78e06cb5bfc7d"},{"application":"BLA018780","submission_no":172,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-08-22","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s172ltr.pdf","untrusted":true}}],"fact_id":"e915979f94344d5c97b40231"},{"application":"BLA018780","submission_no":168,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-11-06","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s168ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s168lbl.pdf","untrusted":true}}],"fact_id":"9c0807a1d333344564e520e9"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":2,"Over-the-counter":2},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA018780","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"HUMULIN R KWIKPEN","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"1500 UNITS/3ML (500 UNITS/ML)","untrusted":true}},{"application":"BLA018780","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"HUMULIN R","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"10000 UNITS/20ML (500 UNITS/ML)","untrusted":true}},{"application":"BLA018780","product_no":"001","te_code":null,"marketing_status":"Over-the-counter","drug_name":{"text":"HUMULIN R","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"100 UNITS/ML","untrusted":true}},{"application":"BLA018780","product_no":"005","te_code":null,"marketing_status":"Over-the-counter","drug_name":{"text":"HUMULIN R PEN","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"100 UNITS/ML","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2026-12-16"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; 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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:BLA018780","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":"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":"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."}