ACTIVE SUBSTANCE / INN

AZACITIDINE

Brand name(s): VIDAZA, Azacitidine Kabi, Azacitidine Celgene, Azacitidine Accord, ONUREG, AZACITIDINE, Onureg, Vidaza, Azacitidine Mylan, Azacitidine betapharm
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;…
NDA214120
ACTIVE SUBSTANCE
Azacitidine
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, Celgene Europe BV, BRISTOL
TOTAL APPLICATIONS
12
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AZACITIDINEANDA210748LUPIN LTDDiscontinued
AZACITIDINEANDA211549AMNEALPrescription
ONUREGNDA214120BRISTOLPrescription
AZACITIDINEANDA218751TEVA PHARMACEUTICALS DEVELOPMENT INCNone (Tentative Approval)
VIDAZANDA050794BRISTOL-MYERSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OnuregBristol-Myers Squibb Pharma EEIGAuthorised17/06/2021Leukemia, Myeloid, Acute
Azacitidine KabiFresenius Kabi Deutschland GmbHAuthorised05/01/2024Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…
Azacitidine MylanMylan Pharmaceuticals LimitedAuthorised27/03/2020Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…
Azacitidine AccordAccord Healthcare S.L.U.Authorised13/02/2020Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…
VidazaBristol-Myers Squibb Pharma EEIGAuthorised17/12/2008Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…
Azacitidine betapharmbetapharm Arzneimittel GmbHAuthorised24/03/2020Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…
Azacitidine CelgeneCelgene Europe BVWithdrawn02/08/2019Myelodysplastic Syndromes;Leukemia, Myelomonocytic, Chronic;Leukemia, Myeloid, A…

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