{"answer":{"query":"Skyclarys","resolved_as":"applications","packages":1,"applications":["NDA216718"],"identity":{"application_numbers":["NDA216718"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2024-11-15","latest":"2024-11-15","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA216718","date":"2033-04-24","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":"8993640","productNo":"001"},"latest_patent_expiry":"2033-04-24","latest_exclusivity_expiry":"2030-02-28","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":3,"fact_id":"2397714c00a58b6da276816b"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA216718","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-04-07","documents":[{"type":"Letter","date":"2026-04-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216718Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-04-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216718s014lbl.pdf","untrusted":true}}],"fact_id":"0d46785bd003515e194e9845"},{"application":"NDA216718","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-20","documents":[{"type":"Label","date":"2024-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s008s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216718Orig1s008,s009ltr.pdf","untrusted":true}}],"fact_id":"cf779ab2a9e738eb01cbaa78"},{"application":"NDA216718","submission_no":8,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-12-20","documents":[{"type":"Label","date":"2024-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s008s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216718Orig1s008,s009ltr.pdf","untrusted":true}}],"fact_id":"eb683db06d2234f21df52fc1"},{"application":"NDA216718","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-25","documents":[{"type":"Label","date":"2024-01-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216718s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-01-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216718Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"ebaaf351e8f301fd52c9438a"}],"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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this compilation is cited with attribution. 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":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"},{"code":"NO_DATA","field":"medicaid_state_utilization","reason":"no CMS State Drug Utilization figure for this drug's packages is in the edition (suppressed, out of scope or unreported)"}],"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."}