FDA.reportPublic FDA data

Application 020327

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISOVUE-200IOPAMIDOLINJECTABLE;INJECTION41%NoNo
002ISOVUE-250IOPAMIDOLINJECTABLE;INJECTION51%YesYes
003ISOVUE-300IOPAMIDOLINJECTABLE;INJECTION61%YesYes
004ISOVUE-370IOPAMIDOLINJECTABLE;INJECTION76%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1315ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1316ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1317ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1317ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1317ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
0270-1317ISOVUEIOPAMIDOLBracco Diagnostics IncNDACurrent
76381-315ISOVUEIOPAMIDOLBIPSO GmbHNDACurrent
76381-316ISOVUEIOPAMIDOLBIPSO GmbHNDACurrent
76381-317ISOVUEIOPAMIDOLBIPSO GmbHNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84776SUPPL 2026-01-20
84756SUPPL 2026-01-15
74072SUPPL 2023-04-27
74068SUPPL 2023-04-26
70249SUPPL2022-02-24
70222SUPPL2022-02-22
52726SUPPL2018-02-26
52688SUPPL2018-02-22
47968SUPPL2017-04-12
47881SUPPL2017-04-06
34506SUPPL2016-01-26
24783SUPPL2016-01-25
34505SUPPL2015-07-09
2334SUPPL2015-07-09
24782SUPPL2014-06-24
34504SUPPL2014-06-23
24781SUPPL2012-08-03
12447SUPPL2012-08-02
24780SUPPL2003-12-11
24779SUPPL2003-07-23