{"answer":{"query":"Combigan","resolved_as":"applications","packages":4,"applications":["NDA021398"],"identity":{"application_numbers":["NDA021398"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"2007-11-14","latest":"2007-11-14","packages_with_a_start_date":4}},"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"LABELING":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA021398","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-17","documents":[{"type":"Letter","date":"2026-03-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021398Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021398s009lbl.pdf","untrusted":true}}],"fact_id":"5eba3410388ab68657e3acaa"},{"application":"NDA021398","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-10-15","documents":[{"type":"Letter","date":"2015-10-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021398Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2015-10-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021398s007lbl.pdf","untrusted":true}}],"fact_id":"5671df38ae961dce2649a5fe"},{"application":"NDA021398","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2012-10-11","documents":[{"type":"Letter","date":"2012-10-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021398Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2012-10-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021398s006lbl.pdf","untrusted":true}}],"fact_id":"e6fc3a2711f3788057105178"}],"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; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA021398","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"COMBIGAN","untrusted":true},"form":{"text":"SOLUTION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"0.2%;EQ 0.5% BASE","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class II":1,"Class III":1},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-1056-2019","classification":"Class II","status":"Terminated","report_date":"2019-04-03","recall_initiated":"2019-03-19","recalling_firm":{"text":"Allergan Sales, LLC","untrusted":true},"reason":{"text":"cGMP Deviations","untrusted":true},"packages_named":4,"fact_id":"e4fd5509c18d503f915b0b71"},{"recall_number":"D-0077-2018","classification":"Class III","status":"Terminated","report_date":"2017-11-22","recall_initiated":"2017-10-19","recalling_firm":{"text":"Allergan Sales, LLC","untrusted":true},"reason":{"text":"Failed Impurities/Degradation Specifications.","untrusted":true},"packages_named":4,"fact_id":"fd317b83bfbb0c066c7d47d8"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Brimonidine Tartrate/Timolol","untrusted":true},"brand":{"text":"Combigan","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":379353448.9,"claims":1229907,"beneficiaries":269143,"average_spending_per_claim_usd":308.44075926,"fact_id":"e01314ac79ab74cdda579d91"},{"year":2021,"gross_spending_usd":392681109.22,"claims":1166848,"beneficiaries":262504,"average_spending_per_claim_usd":336.53150129,"fact_id":"d98f86e383cb92ccb439d61b"},{"year":2022,"gross_spending_usd":291993108.35,"claims":805567,"beneficiaries":208466,"average_spending_per_claim_usd":362.46905391,"fact_id":"3a96139974db33ac82a8b8eb"},{"year":2023,"gross_spending_usd":232102952.78,"claims":610114,"beneficiaries":144502,"average_spending_per_claim_usd":380.42554798,"fact_id":"a0da05bc9cf22bdf9711c498"},{"year":2024,"gross_spending_usd":162254896.38,"claims":465280,"beneficiaries":114398,"average_spending_per_claim_usd":348.72527592,"fact_id":"bba8dc93e70e847fff8686c9"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":141229.59,"all_states_medicaid_paid_prescriptions":267,"top_states":[{"state":"MA","medicaid_paid_prescriptions":267,"medicaid_reimbursed_usd":141229.59,"total_reimbursed_usd":141229.59,"packages":1,"covers":"all_record_types","fact_id":"ea819f8eb4f7db2cd44a335c"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":64,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"079fb36dd8c7e59cc7dea36d","field":"ndc.listing","entity":"ndc:00023921103"},{"fact_id":"cba3090c3997be4c4a63f0da","field":"ndc.listing","entity":"ndc:00023921105"},{"fact_id":"201f90d77e8230de770d3445","field":"ndc.listing","entity":"ndc:00023921110"},{"fact_id":"5eba3410388ab68657e3acaa","field":"drug.label_event","entity":"application:NDA021398"},{"fact_id":"5671df38ae961dce2649a5fe","field":"drug.label_event","entity":"application:NDA021398"},{"fact_id":"e6fc3a2711f3788057105178","field":"drug.label_event","entity":"application:NDA021398"},{"fact_id":"cc508fc3ab6e2a793815c78a","field":"drug.te_code","entity":"application:NDA021398"},{"fact_id":"b622698dedd27172690bc597","field":"drug.marketing_status","entity":"application:NDA021398"},{"fact_id":"e4fd5509c18d503f915b0b71","field":"ndc.recall","entity":"ndc:00023921115"},{"fact_id":"fd317b83bfbb0c066c7d47d8","field":"ndc.recall","entity":"ndc:00023921103"},{"fact_id":"e01314ac79ab74cdda579d91","field":"drug.partd_spending","entity":"drug:brimonidine-tartrate-timolol|combigan"},{"fact_id":"d98f86e383cb92ccb439d61b","field":"drug.partd_spending","entity":"drug:brimonidine-tartrate-timolol|combigan"},{"fact_id":"3a96139974db33ac82a8b8eb","field":"drug.partd_spending","entity":"drug:brimonidine-tartrate-timolol|combigan"},{"fact_id":"a0da05bc9cf22bdf9711c498","field":"drug.partd_spending","entity":"drug:brimonidine-tartrate-timolol|combigan"},{"fact_id":"bba8dc93e70e847fff8686c9","field":"drug.partd_spending","entity":"drug:brimonidine-tartrate-timolol|combigan"},{"fact_id":"ea819f8eb4f7db2cd44a335c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023921105:MA"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. 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":"generic_entry:NDA021398","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"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":"AMBIGUOUS","field":"spending","reason":"4 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is 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."}