FDA.reportPublic FDA data

Application 208036

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001E-Z-HDBARIUM SULFATEFOR SUSPENSION;ORAL98% (334GM/BOT)YesYes
002E-Z-PAQUEBARIUM SULFATEFOR SUSPENSION;ORAL96% (169GM/BOT)YesYes
003E-Z-CAT DRYBARIUM SULFATEFOR SUSPENSION;ORAL40% (9GM/POUCH)YesNo
004VARIBAR THIN LIQUIDBARIUM SULFATEFOR SUSPENSION;ORAL81% (120GM/BOT)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
32909-105Varibar Thin Liquidbarium sulfateE-Z-EM Canada IncNDACurrent
32909-750E-Z-Paquebarium sulfateE-Z-EM Canada IncNDACurrent
32909-750E-Z-Paquebarium sulfateE-Z-EM Canada IncNDACurrent
32909-764E-Z-HDbarium sulfateE-Z-EM Canada IncNDACurrent
32909-764E-Z-HDbarium sulfateE-Z-EM Canada IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58520SUPPL2019-05-02
58504SUPPL2019-05-01
48044SUPPL2017-04-14
47905SUPPL2017-04-10
47157SUPPL2017-02-09
47146SUPPL2017-02-09
46674SUPPL2017-01-05
46666SUPPL2017-01-04
46004ORIG2016-12-02
40614ORIG2016-01-12
32881ORIG2016-01-12
63225ORIG1900-01-01
51876ORIG1900-01-01