HOME › DRUGS › DABIGATRAN ETEXILATE MESYLATE
ACTIVE SUBSTANCE / INN

DABIGATRAN ETEXILATE MESYLATE

Brand name(s): PRADAXA, DABIGATRAN ETEXILATE MESYLATE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA207922
ANDA208040
ACTIVE SUBSTANCE
Dabigatran Etexilate Mesylate
REGULATORS
FDA
SPONSORS / MAH
BRECKENRIDGE, ALEMBIC PHARMS LTD, ALKEM LABS LTD
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DABIGATRAN ETEXILATE MESYLATEANDA208040ALKEM LABS LTDPrescription
PRADAXANDA022512BOEHRINGER INGELHEIMPrescription
DABIGATRAN ETEXILATE MESYLATEANDA207922BRECKENRIDGEDiscontinued
DABIGATRAN ETEXILATE MESYLATEANDA208046ALEMBIC PHARMS LTDNone (Tentative Approval)

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