FDA.reportPublic FDA data

Application 021357

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MULTIHANCEGADOBENATE DIMEGLUMINEINJECTABLE;INTRAVENOUS2.645GM/5ML (529MG/ML)YesYes
002MULTIHANCEGADOBENATE DIMEGLUMINEINJECTABLE;INTRAVENOUS5.29GM/10ML (529MG/ML)YesYes
003MULTIHANCEGADOBENATE DIMEGLUMINEINJECTABLE;INTRAVENOUS7.935GM/15ML (529MG/ML)YesYes
004MULTIHANCEGADOBENATE DIMEGLUMINEINJECTABLE;INTRAVENOUS10.58GM/20ML (529MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-5164MultiHancegadobenate dimeglumineBRACCO DIAGNOSTICS INCNDACurrent
0270-5164MultiHancegadobenate dimeglumineBRACCO DIAGNOSTICS INCNDACurrent
0270-5164MultiHancegadobenate dimeglumineBRACCO DIAGNOSTICS INCNDACurrent
0270-5164MultiHancegadobenate dimeglumineBRACCO DIAGNOSTICS INCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81499SUPPL 2025-03-07
81498SUPPL 2025-03-07
81450SUPPL 2025-03-06
79418SUPPL 2024-08-16
79405SUPPL 2024-08-16
79203SUPPL 2024-07-24
79186SUPPL 2024-07-24
77336SUPPL 2024-02-01
77344SUPPL 2024-01-29
56863SUPPL2018-12-20
56436SUPPL2018-11-14
56308SUPPL2018-11-06
53900SUPPL2018-05-01
53899SUPPL2018-05-01
53828SUPPL2018-04-27
53827SUPPL2018-04-27
51870SUPPL2018-01-26
51343SUPPL2018-01-19
49786SUPPL2017-09-19
49768SUPPL2017-09-18
36747SUPPL2013-08-09
5156SUPPL2013-08-01
36746SUPPL2012-07-10
5155SUPPL2012-07-09
5154SUPPL2010-12-22
15283SUPPL2010-12-20
5153SUPPL2010-03-22
15282SUPPL2010-03-18
27580SUPPL2009-11-10
15281SUPPL2009-10-14
27579SUPPL2007-09-06
15280SUPPL2007-09-06
23649ORIG2006-06-09
21614ORIG2005-03-28
36745ORIG2004-12-03
5152ORIG2004-12-02
53281ORIG1900-01-01
53280ORIG1900-01-01
53279ORIG1900-01-01