{"answer":{"query":"Trulance","resolved_as":"applications","packages":4,"applications":["NDA208745"],"identity":{"application_numbers":["NDA208745"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2017-02-21","latest":"2017-02-21","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA208745","date":"2034-06-05","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":"10011637","productNo":"001"},"latest_patent_expiry":"2034-06-05","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":0,"fact_id":"4af25ebc622109ee2022a6e9"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208745","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-04-13","documents":[{"type":"Letter","date":"2021-04-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-04-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf","untrusted":true}}],"fact_id":"b31dde570db3b680535eef41"},{"application":"NDA208745","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-02-10","documents":[{"type":"Letter","date":"2021-02-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208745Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s007lbl.pdf","untrusted":true}}],"fact_id":"22cf1810f7a4869dd90804c3"},{"application":"NDA208745","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-10-29","documents":[{"type":"Letter","date":"2020-12-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208745Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-12-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208745s010lbl.pdf","untrusted":true}}],"fact_id":"8390ff2229387b4ec176c0af"},{"application":"NDA208745","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-07-25","documents":[{"type":"Letter","date":"2018-07-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s002Ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-10-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s002lbl.pdf","untrusted":true}}],"fact_id":"5196baa015e31c5421f866be"},{"application":"NDA208745","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2018-01-24","documents":[{"type":"Label","date":"2018-01-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-01-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208745Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"ac490aafdc0f09d6c0e69d16"}],"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":"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."}