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ACTIVE SUBSTANCE / INN

OXCARBAZEPINE

Brand name(s): OXTELLAR XR, OXCARBAZEPINE, OXCARBAZEPINE EXTENDED RELEASE TABLETS, TRILEPTAL
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA202810
ANDA206576
ACTIVE SUBSTANCE
Oxcarbazepine
REGULATORS
FDA
SPONSORS / MAH
TWI PHARMS INC, JUBILANT CADISTA, NOVARTIS
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OXCARBAZEPINEANDA077747RUBICON RESEARCHPrescription
OXCARBAZEPINEANDA206576TWI PHARMS INCNone (Tentative Approval)
OXCARBAZEPINEANDA090239JUBILANT CADISTADiscontinued
OXCARBAZEPINE EXTENDED RELEASE TABLETSANDA219404LUPIN LIMITEDNone (Tentative Approval)
OXTELLAR XRNDA202810SUPERNUS PHARMSPrescription
TRILEPTALNDA021014NOVARTISPrescription

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