{"answer":{"query":"Belbuca","resolved_as":"applications","packages":7,"applications":["NDA207932"],"identity":{"application_numbers":["NDA207932"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"FILM, SOLUBLE","untrusted":true}],"marketing_start":{"earliest":"2017-08-11","latest":"2017-10-01","packages_with_a_start_date":7}},"generic_entry":[{"application":"NDA207932","date":"2032-12-21","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":"9901539","productNo":"002"},"latest_patent_expiry":"2032-12-21","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":21,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"94f06a2125b8a9cc402d26a3"}],"label_history":{"events_total":15,"non_cmc_events":15,"counts_by_class":{"REMS":6,"LABELING":9},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA207932","submission_no":30,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-06-18","documents":[{"type":"Letter","date":"2026-06-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/207932Orig1s030ltr.pdf","untrusted":true}}],"fact_id":"4e2cdb0d84d43d8aafad18a2"},{"application":"NDA207932","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-12-22","documents":[{"type":"Letter","date":"2025-12-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207932Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-01-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207932s029lbl.pdf","untrusted":true}}],"fact_id":"fdce3a9fb4f37db8db8ab717"},{"application":"NDA207932","submission_no":27,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2024-10-31","documents":[{"type":"Letter","date":"2024-11-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207932Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"f72e313ef0e5079a0880a430"},{"application":"NDA207932","submission_no":23,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-15","documents":[{"type":"Label","date":"2023-12-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207932s023lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-12-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207932Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"514aebc06f7136a886a39b5e"},{"application":"NDA207932","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-17","documents":[{"type":"Letter","date":"2022-06-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207932Orig1s019, s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf","untrusted":true}}],"fact_id":"dfbe5925327a2731efc5a6d4"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":7,"te_code_counts":{"NOT_PROVIDED":7},"marketing_status_counts":{"Prescription":7},"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":"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":"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."}