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ACTIVE SUBSTANCE / INN

PREGABALIN

Brand name(s): Pregabalin Viatris Pharma (previously Pregabalin Pfizer), Pregabalin Mylan Pharma, LYRICA, Pregabalin Zentiva k.s., Pregabalin Sandoz, Pregabalin Viatris (previously Pregabalin Mylan), Pregabalin Zentiva, Lyrica, Pregabalin Sandoz GmbH, PREGABALIN, LYRICA CR, Pregabalin Accord
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
Epilepsy;Anxiety Disorders;Neuralgia
NDA021723
ACTIVE SUBSTANCE
Pregabalin
REGULATORS
FDA · EMA
SPONSORS / MAH
Upjohn EESV, PHARMOBEDIENT, Sandoz GmbH
TOTAL APPLICATIONS
14
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PREGABALINANDA091228PHARMOBEDIENTDiscontinued
PREGABALINANDA207799ALKEM LABS LTDPrescription
LYRICANDA021723CP PHARMSPrescription
PREGABALINANDA091221WATSON LABS INCNone (Tentative Approval)
LYRICA CRNDA209501UPJOHNPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Pregabalin ZentivaZentiva, k.s.Authorised17/07/2015Anxiety Disorders;Epilepsy
Pregabalin Viatris (previously Pregabalin Mylan)Viatris LimitedAuthorised24/06/2015Anxiety Disorders;Epilepsy
Pregabalin SandozSandoz GmbHAuthorised19/06/2015Anxiety Disorders;Neuralgia;Epilepsy
Pregabalin Viatris Pharma (previously Pregabalin Pfizer)Viatris Healthcare LimitedAuthorised10/04/2014Anxiety Disorders;Epilepsy
LyricaUpjohn EESVAuthorised05/07/2004Epilepsy;Anxiety Disorders;Neuralgia
Pregabalin AccordAccord Healthcare S.L.U.Authorised28/08/2015Anxiety Disorders;Epilepsy
Pregabalin Sandoz GmbHSandoz GmbHWithdrawn19/06/2015Anxiety Disorders;Epilepsy
Pregabalin Zentiva k.s.Zentiva k.s.Withdrawn27/02/2017Anxiety Disorders;Neuralgia;Epilepsy
Pregabalin Mylan PharmaMylan S.A.S.Withdrawn25/06/2015Anxiety Disorders;Neuralgia;Epilepsy

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