FDA.reportPublic FDA data

Application 011245

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003GASTROGRAFINDIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUMSOLUTION;ORAL, RECTAL66%;10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-0445Gastrografindiatrizoate meglumine and diatrizoate sodiumBracco Diagnostics IncNDACurrent
0270-0445Gastrografindiatrizoate meglumine and diatrizoate sodiumBracco Diagnostics IncNDACurrent
0270-0445Gastrografindiatrizoate meglumine and diatrizoate sodiumBracco Diagnostics IncNDACurrent
0270-0445Gastrografindiatrizoate meglumine and diatrizoate sodiumBracco Diagnostics IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11926SUPPL2005-08-31