{"answer":{"query":"Xospata","resolved_as":"applications","packages":3,"applications":["NDA211349"],"identity":{"application_numbers":["NDA211349"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2018-11-29","latest":"2026-11-02","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA211349","date":"2036-07-01","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":"10786500","productNo":"001"},"latest_patent_expiry":"2036-07-01","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":8,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":8,"exclusivities_listed":0,"fact_id":"440a8f8ac87efe241b3021f3"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"LABELING":1,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA211349","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-01-12","documents":[{"type":"Letter","date":"2022-01-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211349Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-01-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf","untrusted":true}}],"fact_id":"982f1ec11361d241819ecd63"},{"application":"NDA211349","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-05-29","documents":[{"type":"Label","date":"2019-05-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211349s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-06-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211349Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"37c61b5d8a09db8d0ce1f799"}],"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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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"}],"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."}