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ACTIVE SUBSTANCE / INN

CYCLOBENZAPRINE HYDROCHLORIDE

Brand name(s): AMRIX, TONMYA, FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA017821
NDA021777
ACTIVE SUBSTANCE
Cyclobenzaprine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
WATSON LABS, PAR PHARM INC, JANSSEN RES AND DEV
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CYCLOBENZAPRINE HYDROCHLORIDEANDA090478INVAGEN PHARMSPrescription
CYCLOBENZAPRINE HYDROCHLORIDEANDA073143WATSON LABSDiscontinued
FLEXERILNDA017821JANSSEN RES AND DEVDiscontinued
TONMYANDA219428TONIXPrescription
CYCLOBENZAPRINE HYDROCHLORIDEANDA090864PAR PHARM INCNone (Tentative Approval)
AMRIXNDA021777TEVA PHARMS INTLPrescription

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