{"answer":{"query":"Nuplazid","resolved_as":"applications","packages":2,"applications":["NDA207318","NDA210793"],"identity":{"application_numbers":["NDA207318","NDA210793"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, COATED","untrusted":true},{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2018-06-28","latest":"2018-06-28","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA207318","date":"2037-09-23","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":"10517860*PED","productNo":"002"},"latest_patent_expiry":"2037-09-23","latest_exclusivity_expiry":"2029-10-27","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":2,"fact_id":"a4d309a84d6267531adf314a"},{"application":"NDA210793","date":"2039-02-27","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":"10449185*PED","productNo":"001"},"latest_patent_expiry":"2039-02-27","latest_exclusivity_expiry":"2029-10-27","dated_barriers":15,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":2,"fact_id":"8d5a8351be2243a4d0c5dde7"}],"label_history":{"events_total":19,"non_cmc_events":19,"counts_by_class":{"EFFICACY":5,"LABELING":14},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA207318","submission_no":16,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-04-27","documents":[{"type":"Letter","date":"2026-05-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/207318Orig1s016;210793Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207318s016lbl.pdf","untrusted":true}}],"fact_id":"380a8d4359ee7c1604ac45bb"},{"application":"NDA210793","submission_no":14,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-04-27","documents":[{"type":"Letter","date":"2026-05-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/207318Orig1s016;210793Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210793s014lbl.pdf","untrusted":true}}],"fact_id":"9f7c6fb785659185ceebea92"},{"application":"NDA207318","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2026-05-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207318s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207318Orig1s014;210793Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"271d3e6208cb99cc4c072948"},{"application":"NDA210793","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207318s014,210793s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207318Orig1s014;210793Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"418246d0748862003f8e5646"},{"application":"NDA207318","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-09-15","documents":[{"type":"Letter","date":"2023-09-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207318Orig1s012;210793Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-09-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf","untrusted":true}}],"fact_id":"b8160b444ba3ffe4917400e0"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AB":2,"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":2,"Discontinued":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":"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."}