{"answer":{"query":"erleada","resolved_as":"name","packages":2,"applications":["NDA210951"],"identity":{"application_numbers":["NDA210951"],"marketing_categories":["NDA"],"labelers":[{"text":"JANSSEN PRODUCTS, LP","untrusted":true}],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2018-02-14","latest":"2023-02-17","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA210951","date":"2041-01-14","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":"11723898","productNo":"001"},"latest_patent_expiry":"2041-01-14","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":28,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":14,"exclusivities_listed":0,"fact_id":"b518eef8d70499bc12ffa8b3"}],"label_history":{"events_total":15,"non_cmc_events":14,"counts_by_class":{"LABELING":10,"EFFICACY":4},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA210951","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-29","documents":[{"type":"Letter","date":"2026-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210951Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210951s024lbl.pdf","untrusted":true}}],"fact_id":"7b015451d68f168f724c255f"},{"application":"NDA210951","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-05","documents":[{"type":"Letter","date":"2026-03-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210951Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210951s021lbl.pdf","untrusted":true}}],"fact_id":"d5a2e937e72fbd19a29f5173"},{"application":"NDA210951","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-02","documents":[{"type":"Letter","date":"2024-08-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210951Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210951s016lbl.pdf","untrusted":true}}],"fact_id":"d5a4b809cc87c3aa280bfc47"},{"application":"NDA210951","submission_no":14,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-12-19","documents":[{"type":"Letter","date":"2023-12-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210951Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951s014lbl.pdf","untrusted":true}}],"fact_id":"5ba9171c0fc81553038d3b31"},{"application":"NDA210951","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-17","documents":[{"type":"Letter","date":"2023-02-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210951Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210951Orig1s011lbl.pdf","untrusted":true}}],"fact_id":"4e9c0606b59519889853f382"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"AB":1,"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":2},"meaning":"raw FDA codes; 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Each answer lists the facts it rests on."}