{"answer":{"query":"Lynparza","resolved_as":"applications","packages":10,"applications":["NDA208558"],"identity":{"application_numbers":["NDA208558"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2017-08-17","latest":"2025-02-20","packages_with_a_start_date":10}},"generic_entry":[{"application":"NDA208558","date":"2041-10-25","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":"11970530","productNo":"001"},"latest_patent_expiry":"2041-10-25","latest_exclusivity_expiry":"2027-05-08","dated_barriers":28,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":11,"exclusivities_listed":3,"fact_id":"f7a0470c1b9c01957062c55a"}],"label_history":{"events_total":21,"non_cmc_events":21,"counts_by_class":{"LABELING":7,"EFFICACY":14},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208558","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-07-10","documents":[{"type":"Letter","date":"2025-07-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208558Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-07-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208558s031lbl.pdf","untrusted":true}}],"fact_id":"087825ab1cb707411012872f"},{"application":"NDA208558","submission_no":28,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-11-06","documents":[{"type":"Letter","date":"2023-11-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s028ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-11-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf","untrusted":true}}],"fact_id":"545df597946d46d1aa147b51"},{"application":"NDA208558","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-12","documents":[{"type":"Letter","date":"2023-09-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-09-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf","untrusted":true}}],"fact_id":"38bec71393d27627e9f09816"},{"application":"NDA208558","submission_no":25,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-05-31","documents":[{"type":"Label","date":"2023-06-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-06-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s025ltr.pdf","untrusted":true}}],"fact_id":"71a9ed14909e64e7275b7bb8"},{"application":"NDA208558","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-10-27","documents":[{"type":"Letter","date":"2022-10-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208558Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s024lbl.pdf","untrusted":true}}],"fact_id":"14e435b8f298c62030308b40"}],"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":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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."}