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ACTIVE SUBSTANCE / INN

TAPENTADOL HYDROCHLORIDE

Brand name(s): NUCYNTA, TAPENTADOL HYDROCHLORIDE, NUCYNTA ER
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA214378
NDA200533
ACTIVE SUBSTANCE
Tapentadol Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
RHODES PHARMS, COLLEGIUM PHARM INC, HUMANWELL
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
NUCYNTANDA022304COLLEGIUM PHARM INCPrescription
TAPENTADOL HYDROCHLORIDEANDA209369RHODES PHARMSNone (Tentative Approval)
TAPENTADOL HYDROCHLORIDEANDA214378HUMANWELLPrescription
NUCYNTANDA203794COLLEGIUM PHARM INCDiscontinued
NUCYNTA ERNDA200533COLLEGIUM PHARM INCPrescription

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