FDA.reportPublic FDA data

Application 020131

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROHANCEGADOTERIDOLINJECTABLE;INJECTION279.3MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent
0270-1111ProHancegadoteridolBRACCO DIAGNOSTICS INCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81532SUPPL 2025-03-11
81448SUPPL 2025-03-06
79420SUPPL 2024-08-16
79402SUPPL 2024-08-16
79401SUPPL 2024-08-16
79201SUPPL 2024-07-24
79190SUPPL 2024-07-24
77342SUPPL 2024-01-29
77332SUPPL 2024-01-29
72771SUPPL2022-12-05
72746SUPPL2022-11-29
65737SUPPL2020-12-28
65736SUPPL2020-12-28
65694SUPPL2020-12-22
53894SUPPL2018-05-01
53848SUPPL2018-04-27
53847SUPPL2018-04-27
49784SUPPL2017-09-19
49771SUPPL2017-09-18
2052SUPPL2013-08-16
12241SUPPL2013-08-15
21193SUPPL2010-12-22
34287SUPPL2010-12-20
21192SUPPL2007-09-06
12240SUPPL2007-09-06
44045ORIG2006-06-09
21191SUPPL2002-09-30
2051SUPPL2002-09-30