FDA.reportPublic FDA data

Application 021489

Type
NDA
Sponsor
BRACCO

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021489-001PROHANCE MULTIPACKGADOTERIDOL279.3MG/MLINJECTABLE / INJECTIONRLD, RS2003-10-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021489-001PROHANCE MULTIPACK279.3MG/MLINJECTABLE / INJECTIONRLD, RS2003-10-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021489-001PROHANCE MULTIPACK279.3MG/MLINJECTABLE / INJECTIONRLD, RS2003-10-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021489-001PROHANCE MULTIPACK279.3MG/MLINJECTABLE / INJECTIONRLD, RS2003-10-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021489-001PROHANCE MULTIPACK279.3MG/MLINJECTABLE / INJECTIONRLD, RS2003-10-09a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProHanceGADOTERIDOLBRACCO DIAGNOSTICS INC778aee03-7d4c-481a-be8a-a75db0702f5a2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0270-1111
ProHanceGADOTERIDOLBracco Diagnostics Ince8b76200-c0aa-491b-aad7-e22d2f68496f2025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021489
application number: NDA021489
ndc (product): 0270-1111

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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