Busulfan Injectable Solution

Brand(s)
Busulfex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Otsuka America Pharmaceutical, Inc. (2015-11-17)
Oldest Current Product
1999-02-04
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\BUSULFAN
FDAOB
INJECTION\INJECTION\BUSULFAN\rdfq
SPL Active
INTRAVENOUS\INJECTION\BUSULFAN
SPL Moiety
INTRAVENOUS\INJECTION\BUSULFAN

product(s) by strength(s)

busulfan 6 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480070BusulfexNDAOtsuka America Pharmaceutical, Inc.1999-02-04BUSULFANINTRAVENOUSINJECTIONNDA0209545cb9d285-1803-4a99-946a-d0b239b32df6

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020954BUSULFEXOTSUKA PHARMACEUTICAL CO LTD1999-02-04NDA020954_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020954_001RXBUSULFAN (6MG/ML)INJECTIONTrue1999-02-04BUSULFEX

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15cb9d285-1803-4a99-946a-d0b239b32df6 (view SPL)These highlights do not include all the information needed to use BUSULFEX safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) for injection Initial U.S. Approval: 1999prescriptionHuman PrescriptionOtsuka America Pharmaceutical, Inc.2015-11-1714591480070

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII