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ACTIVE SUBSTANCE / INN

BUPRENORPHINE

Brand name(s): BUTRANS, Sixmo, Buprenorphine Neuraxpharm, BRIXADI, SUBLOCADE, Buvidal, BUPRENORPHINE
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA210136
ANDA207490
ACTIVE SUBSTANCE
Buprenorphine
REGULATORS
FDA · EMA
SPONSORS / MAH
DIFGEN PHARMS, Neuraxpharm Pharmaceuticals S.L., Camurus AB
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BRIXADINDA210136BRAEBURNPrescription
BUPRENORPHINEANDA210272DIFGEN PHARMSPrescription
BUTRANSNDA021306PURDUE PHARMA LPPrescription
BUPRENORPHINEANDA207490STRIDES PHARMA INTLDiscontinued
SUBLOCADENDA209819INDIVIORPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SixmoL. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.Withdrawn19/06/2019Opioid-Related Disorders
Buprenorphine NeuraxpharmNeuraxpharm Pharmaceuticals S.L.Authorised19/12/2024Opioid-Related Disorders
BuvidalCamurus ABAuthorised20/11/2018Opioid-Related Disorders

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