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ACTIVE SUBSTANCE / INN

SODIUM OXYBATE

Brand name(s): Xyrem, LUMRYZ, SODIUM OXYBATE, XYWAV, XYREM
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA202090
NDA212690
ACTIVE SUBSTANCE
Sodium Oxybate
REGULATORS
FDA · EMA
SPONSORS / MAH
UCB Pharma Ltd, HIKMA, AVADEL CNS
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SODIUM OXYBATEANDA202090HIKMADiscontinued
XYREMNDA021196JAZZ PHARMSPrescription
SODIUM OXYBATEANDA210523ASCENT PHARMS INCPrescription
SODIUM OXYBATEANDA203351OHM LABS INCNone (Tentative Approval)
XYWAVNDA212690JAZZPrescription
LUMRYZNDA214755AVADEL CNSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
XyremUCB Pharma LtdAuthorised13/10/2005Cataplexy;Narcolepsy

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