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ACTIVE SUBSTANCE / INN

DOXORUBICIN HYDROCHLORIDE

Brand name(s): DOXIL (LIPOSOMAL), RUBEX, Celdoxome pegylated liposomal, DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), ADRIAMYCIN PFS, DOXORUBICIN HYDROCHLORIDE
FDA LISTED
EMA LISTED
PRESCRIPTION
LAPSED
DISCONTINUED
ANDA065515
ANDA063277
ACTIVE SUBSTANCE
Doxorubicin Hydrochloride
REGULATORS
FDA · EMA
SPONSORS / MAH
BRISTOL MYERS SQUIBB, BAXTER HLTHCARE CORP, ALMAJECT
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DOXORUBICIN HYDROCHLORIDEANDA063277FRESENIUS KABI USAPrescription
DOXORUBICIN HYDROCHLORIDEANDA065515ALMAJECTDiscontinued
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)ANDA212219BAXTER HLTHCARE CORPPrescription
RUBEXANDA062926BRISTOL MYERS SQUIBBDiscontinued
ADRIAMYCIN PFSANDA063165PFIZERDiscontinued
DOXIL (LIPOSOMAL)NDA050718BAXTER HLTHCARE CORPPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Celdoxome pegylated liposomalBaxter Holding B.V.Lapsed15/09/2022Breast Neoplasms;Ovarian Neoplasms;Multiple Myeloma;Sarcoma, Kaposi

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