{"answer":{"query":"Lokelma","resolved_as":"applications","packages":8,"applications":["NDA207078"],"identity":{"application_numbers":["NDA207078"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"POWDER, FOR SUSPENSION","untrusted":true}],"marketing_start":{"earliest":"2018-09-04","latest":"2024-02-01","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA207078","date":"2035-10-14","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":"10300087","productNo":"001"},"latest_patent_expiry":"2035-10-14","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":27,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":14,"exclusivities_listed":0,"fact_id":"bc90142409cc7b691bf085c0"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA207078","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-08","documents":[{"type":"Letter","date":"2024-02-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207078Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207078s010lbl.pdf","untrusted":true}}],"fact_id":"964e29203b227027e1260e87"},{"application":"NDA207078","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-30","documents":[{"type":"Letter","date":"2022-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207078Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207078s008lbl.pdf","untrusted":true}}],"fact_id":"885fca9e85c941ab14de2b62"},{"application":"NDA207078","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-10-19","documents":[{"type":"Label","date":"2021-10-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207078s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207078Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"3f9007c3362303545aa2cf9a"},{"application":"NDA207078","submission_no":3,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-04-24","documents":[{"type":"Label","date":"2020-04-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207078s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-04-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207078Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"313fbc8e7cd90c43b4757850"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"AB":2},"marketing_status_counts":{"Prescription":2},"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":"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."}