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ACTIVE SUBSTANCE / INN

METHYLPHENIDATE HYDROCHLORIDE

Brand name(s): METADATE CD, QUILLIVANT XR, QUILLICHEW ER, Tuzulby, METHYLIN, RITALIN LA, JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA210764
NDA021284
ACTIVE SUBSTANCE
Methylphenidate Hydrochloride
REGULATORS
FDA · EMA
SPONSORS / MAH
Neuraxpharm Pharmaceuticals S.L., ANDA REPOSITORY, SANDOZ
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
METHYLPHENIDATE HYDROCHLORIDEANDA204772ALVOGENDiscontinued
QUILLICHEW ERNDA207960NEXTWAVE PHARMSPrescription
METHYLPHENIDATE HYDROCHLORIDEANDA210764ANDA REPOSITORYPrescription
METHYLPHENIDATE HYDROCHLORIDEANDA214202TEVA PHARMS USANone (Tentative Approval)
METADATE CDNDA021259AYTU BIOPHARMAPrescription
QUILLIVANT XRNDA202100NEXTWAVEPrescription
METHYLINNDA021419SPECGX LLCPrescription
METHYLINNDA021475SPECGX LLCDiscontinued
JORNAY PMNDA209311IRONSHORE PHARMSPrescription
RITALIN LANDA021284SANDOZPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TuzulbyNeuraxpharm Pharmaceuticals S.L.Authorised28/02/2025Attention Deficit Disorder with Hyperactivity

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