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ACTIVE SUBSTANCE / INN

MIDAZOLAM

Brand name(s): MIDAZOLAM IN 0.9% SODIUM CHLORIDE, MIDAZOLAM IN 0.8% SODIUM CHLORIDE, MIDAZOLAM, Buccolam, Omforro, Tuzodi, NAYZILAM
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
Conscious Sedation;Anesthesia
ANDA218454
ACTIVE SUBSTANCE
Midazolam
REGULATORS
FDA · EMA
SPONSORS / MAH
EXELA PHARMA, CIPLA LTD, Neuraxpharm Pharmaceuticals S.L.
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MIDAZOLAM IN 0.9% SODIUM CHLORIDEANDA218993GLANDPrescription
MIDAZOLAM IN 0.8% SODIUM CHLORIDENDA215868EXELA PHARMADiscontinued
MIDAZOLAMANDA216048CIPLA LTDNone (Tentative Approval)
MIDAZOLAM IN 0.8% SODIUM CHLORIDEANDA218454B BRAUN MEDICALPrescription
NAYZILAMNDA211321UCB INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OmforroRegulatory Pharma Net S.r.l.Application withdrawnConscious Sedation;Anesthesia
TuzodiRegulatory Pharma Net S.r.l.Application withdrawnSeizures
BuccolamNeuraxpharm Pharmaceuticals S.L.Authorised04/09/2011Epilepsy

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