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ACTIVE SUBSTANCE / INN

PRALATREXATE

Brand name(s): Folotyn, FOLOTYN, PRALATREXATE
FDA LISTED
EMA LISTED
PRESCRIPTION
REFUSED
NONE (TENTATIVE APPROVAL)
NDA022468
Lymphoma, T-Cell
ACTIVE SUBSTANCE
Pralatrexate
REGULATORS
FDA · EMA
SPONSORS / MAH
Allos Therapeutics Ltd, ACROTECH BIOPHARMA, TEVA PHARMS USA INC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PRALATREXATEANDA206183DR REDDYSPrescription
FOLOTYNNDA022468ACROTECH BIOPHARMAPrescription
PRALATREXATEANDA206167TEVA PHARMS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
FolotynAllos Therapeutics LtdRefusedLymphoma, T-Cell

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