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Versed, Buccolam(midazolam maleate)
Buccolam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
mental disordersD001523
Trade Name
FDA
EMA
Nayzilam, Seizalam (generic drugs available since 2000-06-20, discontinued: Midozalam, Versed)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midazolam
Tradename
Company
Number
Date
Products
MIDAZOLAM IN 0.8% SODIUM CHLORIDEExela Pharma SciencesN-215868 RX2022-07-20
2 products, RLD, RS
MIDAZOLAM IN 0.9% SODIUM CHLORIDEInfoRLifeN-211844 RX2021-03-22
2 products, RLD, RS
NAYZILAMUCBN-211321 RX2019-05-17
1 products, RLD, RS
Midazolam hydrochloride
Tradename
Company
Number
Date
Products
SEIZALAMMeridian Medical TechnologiesN-209566 RX2018-09-14
1 products, RLD, RS
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)Rafa LaboratoriesN-216359 PEND2022-08-08
1 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
midazolam ANDA2023-05-16
nayzilamNew Drug Application2021-02-11
seizalam New Drug Application2021-11-26
versed spf 30 replenishing body mineralOTC monograph final2023-05-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anxiety disordersEFO_0006788D001008F41.1
psychomotor agitationD011595
status epilepticusEFO_0008526D013226G41
Agency Specific
FDA
EMA
Expiration
Code
MIDAZOLAM, NAYZILAM, UCB INC
2026-05-17ODE-243
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT
2025-09-14ODE-207
Patent Expiration
Patent
Expires
Flag
FDA Information
Midazolam, Midazolam In 0.9% Sodium Chloride, Inforlife
109669902038-06-20DP
Midazolam, Nayzilam, Ucb Inc
82170332028-01-18DPU-2526
88093222028-01-18DP
92894322028-01-18DPU-2526
96874952028-01-18DPU-2526
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05C: Hypnotics and sedatives
N05CD: Benzodiazepine derivative hypnotics and sedatives
N05CD08: Midazolam
HCPCS
No data
Clinical
Clinical Trials
922 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients141122146
AnesthesiaD000758314111028
AnxietyD001007EFO_0005230F41.1141111127
NeoplasmsD009369C802321226
Major depressive disorderD003865EFO_0003761F225835321
PainD010146EFO_0003843R52435719
Postoperative painD010149G89.182622715
DeliriumD003693R41.0115411
Critical illnessD016638244311
Conscious sedationD016292125210
Show 129 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5052118
Post-traumatic stress disordersD013313EFO_0001358F43.16318
Respiratory insufficiencyD012131HP_0002093J96.911147
Acute painD059787R521134
Low back painD017116HP_0003419M54.5123
Inguinal herniaD006552HP_0000023K40112
Chronic painD059350HP_0012532112
Renal insufficiencyD051437HP_0000083N19112
Procedural painD00007381822
HypertensionD006973EFO_0000537I10112
Show 22 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obsessive-compulsive disorderD009771EFO_0004242F421314
Pulmonary tuberculosisD014397EFO_1000049A15213
CandidiasisD002177B3722
Male breast neoplasmsD018567112
TonsillitisD014069HP_0011110J03112
Myeloid leukemia acuteD015470C92.0222
Status epilepticusD013226EFO_0008526G41112
HypotensionD007022EFO_0005251I95112
Radical mastectomyD015409111
LiposarcomaD008080111
Show 29 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD00434715217
Type 2 diabetes mellitusD003924EFO_0001360E1177
PsoriasisD011565EFO_0000676L4066
Rheumatoid arthritisD001172EFO_0000685M06.966
MelanomaD00854533
Non-hodgkin lymphomaD008228C85.933
TuberculosisD014376EFO_0000774A15-A1933
AmnesiaD000647EFO_1001454F44.033
Chronic hepatitis bD019694EFO_0004197B18.133
Lung diseasesD008171EFO_0003818J98.4123
Show 60 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychomotor agitationD01159555
Stomach neoplasmsD013274EFO_0003897C1622
Spine osteoarthritisD055013EFO_100078711
RhytidoplastyD01536111
AcrodyniaD000170EFO_100175611
Neoplasm metastasisD009362EFO_000970811
Alpha 1-antitrypsin deficiencyD019896E88.0111
Argininosuccinic aciduriaD05680711
Perioperative periodD05903511
Sepsis-associated encephalopathyD065166G93.4111
Show 48 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMIDAZOLAM MALEATE
INNmidazolam
Description
Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes.
Classification
Small molecule
Drug classBenzodiazepine
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O
Identifiers
PDB
CAS-ID59467-70-8
RxCUI6960
ChEMBL IDCHEMBL2106922
ChEBI ID
PubChem CID4192
DrugBankDB00683
UNII IDR60L0SM5BC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 56,348 documents
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Safety
Black-box Warning
Black-box warning for: Midazolam , Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
Mock data
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1 adverse events reported
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