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ACTIVE SUBSTANCE / INN

MESALAMINE

Brand name(s): ASACOL, PENTASA, DELZICOL, CANASA, SFROWASA, ASACOL HD, ROWASA, MESALAMINE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NDA021830
ANDA210509
ACTIVE SUBSTANCE
Mesalamine
REGULATORS
FDA
SPONSORS / MAH
ABBVIE, TAKEDA PHARMS USA, AMNEAL
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ROWASANDA019618MYLAN SPECIALITY LPPrescription
SFROWASANDA019618MYLAN SPECIALITY LPPrescription
MESALAMINEANDA210509AMNEALDiscontinued
MESALAMINEANDA207873TEVA PHARMS USAPrescription
PENTASANDA020049TAKEDA PHARMS USAPrescription
ASACOL HDNDA021830ABBVIEDiscontinued
CANASANDA021252ABBVIEDiscontinued
CANASANDA021252ABBVIEPrescription
ASACOLNDA019651APILDiscontinued
DELZICOLNDA204412ABBVIEDiscontinued

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