{"answer":{"query":"Gattex","resolved_as":"applications","packages":3,"applications":["NDA203441"],"identity":{"application_numbers":["NDA203441"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2012-12-21","latest":"2012-12-21","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA203441","date":"2026-05-16","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":"exclusivity","ref":"ODE-240","productNo":"001"},"latest_patent_expiry":"2026-05-01","latest_exclusivity_expiry":"2026-05-16","dated_barriers":5,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":1,"fact_id":"d668e186a18c03f1ae99a2b4"}],"label_history":{"events_total":18,"non_cmc_events":13,"counts_by_class":{"REMS":6,"LABELING":4,"EFFICACY":3},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA203441","submission_no":28,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-08-26","documents":[{"type":"Letter","date":"2026-08-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203441Orig1s028ltr.pdf","untrusted":true}}],"fact_id":"d2bade3b1d1521f3a2b20409"},{"application":"NDA203441","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-09-05","documents":[{"type":"Letter","date":"2025-09-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203441Orig1s24ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-09-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203441s024lbl.pdf","untrusted":true}}],"fact_id":"11f73dc6ed2285f136463aad"},{"application":"NDA203441","submission_no":23,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-08-13","documents":[{"type":"Letter","date":"2025-08-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203441Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"8e2fc0a1e97f99e25b812284"},{"application":"NDA203441","submission_no":22,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-09-19","documents":[{"type":"Label","date":"2024-09-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203441s022lbl.pdf","untrusted":true}}],"fact_id":"7415991413f20dbbe6ff9e51"},{"application":"NDA203441","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-01-24","documents":[{"type":"Letter","date":"2023-01-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203441Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-01-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203441Orig1s016lbl.pdf","untrusted":true}}],"fact_id":"bac5c41b08a3beeb7bf9d854"}],"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":"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."}