{"answer":{"query":"Lorbrena","resolved_as":"applications","packages":4,"applications":["NDA210868"],"identity":{"application_numbers":["NDA210868"],"marketing_categories":["NDA"],"labelers":[{"text":"PFIZER LABORATORIES DIV PFIZER INC","untrusted":true}],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2018-11-19","latest":"2025-01-03","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA210868","date":"2038-10-04","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":"11299500","productNo":"001"},"latest_patent_expiry":"2038-10-04","latest_exclusivity_expiry":"2028-03-03","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":1,"fact_id":"0b26bf375f806f76356eec0e"}],"label_history":{"events_total":6,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA210868","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-29","documents":[{"type":"Letter","date":"2026-01-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210868Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210868s008lbl.pdf","untrusted":true}}],"fact_id":"4e57316951fb34e66b4f0a25"},{"application":"NDA210868","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-03-03","documents":[{"type":"Label","date":"2021-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-03-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"8e4bde308c9beefd050ce20a"},{"application":"NDA210868","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-02-26","documents":[{"type":"Label","date":"2021-03-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"d3a2d311877b5e27e0c6407e"},{"application":"NDA210868","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-01-22","documents":[{"type":"Letter","date":"2021-01-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210868Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-01-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210868s002lbl.pdf","untrusted":true}}],"fact_id":"2eaf408c6d55e97f1597a14b"},{"application":"NDA210868","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-05-29","documents":[{"type":"Label","date":"2020-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210868s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210868Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"d6165b96b3b59fa1183d315f"}],"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":"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."}