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ACTIVE SUBSTANCE / INN

BACLOFEN

Brand name(s): OZOBAX, GABLOFEN, BACLOFEN, OZOBAX DS, LYVISPAH, FLEQSUVY, LIORESAL, KEMSTRO
FDA LISTED
PRESCRIPTION
DISCONTINUED
ANDA077088
NDA215422
ACTIVE SUBSTANCE
Baclofen
REGULATORS
FDA
SPONSORS / MAH
PIRAMAL CRITICAL, AZURITY, AMNEAL
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BACLOFENANDA077088OXFORD PHARMSPrescription
BACLOFENANDA077971IMPAXDiscontinued
LYVISPAHNDA215422STRIDES PHARMA INTLDiscontinued
OZOBAX DSNDA208193METACEL PHARMS LLCPrescription
OZOBAXNDA208193METACEL PHARMS LLCDiscontinued
GABLOFENNDA022462PIRAMAL CRITICALPrescription
FLEQSUVYNDA215602AZURITYPrescription
LIORESALNDA020075AMNEALPrescription
KEMSTRONDA021589UCB INCDiscontinued
LIORESALNDA017851NOVARTISDiscontinued

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