FDA.reportPublic FDA data

Application 020954

Type
NDA
Sponsor
OTSUKA PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUSULFEXBUSULFANINJECTABLE;INJECTION6MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-047BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-047BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-047BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-070BUSULFEXbusulfanOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64095SUPPL2020-07-27
62130SUPPL2020-03-12
55797SUPPL2018-10-03
55796SUPPL2018-10-03
55767SUPPL2018-10-01
55766SUPPL2018-10-01
52107SUPPL2018-01-30
51912SUPPL2018-01-26
13811SUPPL2016-05-23
26292SUPPL2016-05-20
35713SUPPL2015-01-20
3843SUPPL2015-01-20
35712SUPPL2011-06-29
26291SUPPL2011-06-29
13810SUPPL2011-06-29
3842SUPPL2011-06-29
26290SUPPL2007-04-25
35711SUPPL2007-04-20
41836SUPPL2004-06-04
41835SUPPL2004-03-09
41834SUPPL2004-03-09
21301SUPPL2003-07-08
35709SUPPL2003-03-06
26288SUPPL2003-01-13
3840SUPPL2002-12-23
35710SUPPL2002-11-13
26289SUPPL2002-11-13
3841SUPPL2002-04-24
21300ORIG1999-06-14
35708ORIG1999-02-04
3839ORIG1999-02-04