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ACTIVE SUBSTANCE / INN

ACALABRUTINIB

Brand name(s): CALQUENCE, Calquence, ACALABRUTINIB
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
Leukemia, Lymphocytic, Chronic, B-Cell
ANDA216775
ACTIVE SUBSTANCE
Acalabrutinib
REGULATORS
FDA · EMA
SPONSORS / MAH
ALEMBIC PHARMS LTD, ASTRAZENECA, AstraZeneca AB
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CALQUENCENDA210259ASTRAZENECAPrescription
ACALABRUTINIBANDA216775ALEMBIC PHARMS LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
CalquenceAstraZeneca ABAuthorised05/11/2020Leukemia, Lymphocytic, Chronic, B-Cell

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