FDA.reportPublic FDA data

Application 019414

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDIOGEN-82RUBIDIUM CHLORIDE RB-82INJECTABLE;INJECTIONN/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent
0270-0091CardioGen-82Rubidium Chloride RB-82Bracco Diagnostics IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85924SUPPL 2026-05-18
85899SUPPL 2026-05-13
80752SUPPL 2024-12-27
80742SUPPL 2024-12-27
64935SUPPL2020-10-16
64926SUPPL2020-10-16
60666SUPPL2019-10-25
60665SUPPL2019-10-25
58470SUPPL2019-04-30
58469SUPPL2019-04-26
1318SUPPL2012-02-10
11502SUPPL2012-02-09
44033ORIG2012-01-12
11501SUPPL2010-07-31
17388SUPPL2010-07-30
11500SUPPL2009-07-23
1317SUPPL2009-07-23
1316SUPPL2001-04-11