FDA.reportPublic FDA data

Application 021489

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROHANCE MULTIPACKGADOTERIDOLINJECTABLE;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
0270-1111ProHancegadoteridolBracco Diagnostics IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81533SUPPL 2025-03-11
81449SUPPL 2025-03-06
79421SUPPL 2024-08-16
79404SUPPL 2024-08-16
79403SUPPL 2024-08-16
79202SUPPL 2024-07-24
79192SUPPL 2024-07-24
77343SUPPL 2024-01-29
77334SUPPL 2024-01-29
72674SUPPL2022-11-23
72671SUPPL2022-11-22
67473SUPPL2021-05-12
67443SUPPL2021-05-10
65739SUPPL2020-12-28
65738SUPPL2020-12-28
65670SUPPL2020-12-22
56435SUPPL2018-11-14
56311SUPPL2018-11-06
53895SUPPL2018-05-01
53846SUPPL2018-04-27
53845SUPPL2018-04-27
49780SUPPL2017-09-19
49774SUPPL2017-09-19
15591SUPPL2014-07-24
5530SUPPL2014-07-24
27922SUPPL2013-08-16
37061SUPPL2013-08-15
5529SUPPL2010-12-22
15590SUPPL2010-12-20
37060SUPPL2007-09-06
5528SUPPL2007-09-06
21689ORIG2006-07-25
44128ORIG2006-06-09
37059ORIG2003-10-16
5527ORIG2003-10-16