Dyskinesia
Drugs: DUPIXENT, ABILIFY MAINTENA, AUSTEDO +1
- Safetyreportversion
- 1
- Safetyreportid
- 26940083
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20260709
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260630
- Receiptdateformat
- 102
- Receiptdate
- 20260630
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-SA-2026SA0118493
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- SANOFI AVENTIS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Dyskinesia
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugauthorizationnumb
- 761055
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 2
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- 300.000MG QOW
- Drugindication
- Asthma
- Drugstartdateformat
- 610
- Drugstartdate
- 202408
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 2
- Medicinalproduct
- ABILIFY MAINTENA
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- ARIPIPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- NDA202971
- Brand name
- ABILIFY MAINTENA
- Generic name
- ARIPIPRAZOLE
- Manufacturer name
- Otsuka America Pharmaceutical, Inc.
- Product NDC
- 59148-045, 59148-072, 59148-245, 59148-232
- Product type
- HUMAN PRESCRIPTION DRUG
- RxCUI
- 1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816, 1659818
- SPL ID
- 30e40a02-9942-4914-8d84-cf5a8058cec6
- SPL set ID
- ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6
- Package NDC
- 59148-045-80, 59148-072-80, 59148-072-92, 59148-245-12, 59148-238-90, 59148-100-12, 59148-232-12, 59148-235-70
- Drugcharacterization
- 2
- Medicinalproduct
- AUSTEDO
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- DEUTETRABENAZINE
- Harmonized identifiers (openFDA)
- Application number
- NDA208082
- Brand name
- AUSTEDO
- Generic name
- DEUTETRABENAZINE
- Manufacturer name
- Teva Neuroscience, Inc.
- Product NDC
- 68546-170, 68546-171, 68546-172, 68546-177, 68546-176, 68546-181, 68546-182, 68546-470, 68546-471, 68546-472, 68546-490, 68546-473, 68546-474, 68546-475, 68546-476, 68546-477, 68546-479
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- DEUTETRABENAZINE
- RxCUI
- 1876910, 1876916, 1876918, 1876920, 1876922, 1876924, 2281114, 2281115, 2281116, 2281117, 2541518, 2541519, 2541520, 2630144, 2630147, 2630150, 2630153, 2630155, 2630157, 2630159, 2630160, 2683282, 2683285, 2683288, 2683291, 2683294, 2683297, 2683300, 2683303, 2686153, 2686156, 2686612, 2686613
- SPL ID
- 69071a25-792d-4eec-a12a-1bb30c8fc881
- SPL set ID
- 7ea3c60a-45c7-44cc-afc2-d87fa53993c0
- Package NDC
- 68546-170-60, 68546-170-66, 68546-171-60, 68546-171-66, 68546-172-60, 68546-172-66, 68546-177-21, 68546-176-28, 68546-181-49, 68546-182-70, 68546-470-56, 68546-471-56, 68546-472-56, 68546-490-52, 68546-490-42, 68546-161-15, 68546-163-15, 68546-165-15, 68546-473-56, 68546-474-56, 68546-475-56, 68546-476-56, 68546-477-29, 68546-477-28, 68546-191-07, 68546-192-07, 68546-190-07, 68546-193-07, 68546-479-56
- UNII
- P341G6W9NB
- Drugcharacterization
- 2
- Medicinalproduct
- INGREZZA
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- VALBENAZINE DITOSYLATE
- Harmonized identifiers (openFDA)
- Application number
- NDA209241
- Brand name
- INGREZZA
- Generic name
- VALBENAZINE
- Manufacturer name
- Neurocrine Biosciences, Inc.
- Product NDC
- 70370-1060, 70370-2040, 70370-1080, 70370-2048, 70370-2046, 70370-4040, 70370-4060, 70370-4080
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- VALBENAZINE TOSYLATE
- RxCUI
- 1918224, 1918230, 1986329, 1986331, 2054268, 2054269, 2541511, 2541513, 2665627, 2665628, 2680779, 2680780, 2680781, 2680782, 2680783, 2680784
- SPL ID
- bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b
- SPL set ID
- 4c970164-cafb-421f-9eb5-c226ef0a3417
- Package NDC
- 70370-2040-1, 70370-1060-1, 70370-1080-1, 70370-2048-6, 70370-2046-1, 70370-4040-1, 70370-4060-1, 70370-4080-1
- UNII
- 5SML1T733B