{"answer":{"query":"Stivarga","resolved_as":"applications","packages":4,"applications":["NDA203085"],"identity":{"application_numbers":["NDA203085"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2012-09-27","latest":"2021-05-01","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA203085","date":"2032-07-09","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":"9957232","productNo":"001"},"latest_patent_expiry":"2032-07-09","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":4,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"d95f9924cd5b6f44b7409f7b"}],"label_history":{"events_total":15,"non_cmc_events":12,"counts_by_class":{"LABELING":10,"EFFICACY":2},"cmc_events":3,"recent_non_cmc_events":[{"application":"NDA203085","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-03","documents":[{"type":"Letter","date":"2026-02-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203085Orig1s018ltr.pdf","untrusted":true}},{"type":"Letter","date":"2026-02-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203085Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/203085s018lbl.pdf","untrusted":true}}],"fact_id":"2f41f76acfcf305ac9827692"},{"application":"NDA203085","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-25","documents":[{"type":"Letter","date":"2025-02-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203085Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-02-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203085s016lbl.pdf","untrusted":true}}],"fact_id":"61fc1156b86a1db7ca75a866"},{"application":"NDA203085","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-09-24","documents":[{"type":"Letter","date":"2020-09-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"031ff4bf17839c81102ffbd1"},{"application":"NDA203085","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-07-21","documents":[{"type":"Label","date":"2020-07-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-07-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"f7f82ec412c32a992eed3f42"},{"application":"NDA203085","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-02-13","documents":[{"type":"Label","date":"2020-02-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-02-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"a51672f5768e5392f2e8b3e4"}],"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":{"AB":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}