FDA.reportPublic FDA data

Application 208143

Type
NDA
Sponsor
BRACCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001READI-CAT 2BARIUM SULFATESUSPENSION;ORAL2% (9GM/BOT)YesYes
002READI-CAT 2 SMOOTHIEBARIUM SULFATESUSPENSION;ORAL2% (9GM/BOT)YesYes
003LIQUID E-Z-PAQUEBARIUM SULFATESUSPENSION;ORAL60% (213GM/BOT)YesYes
004VARIBAR NECTARBARIUM SULFATESUSPENSION;ORAL40% (96GM/240ML)YesYes
005TAGITOL VBARIUM SULFATESUSPENSION;ORAL40% (8GM/BOT)YesYes
006VARIBAR THIN HONEYBARIUM SULFATESUSPENSION;ORAL40% (100GM/250ML)YesYes
007VARIBAR HONEYBARIUM SULFATESUSPENSION;ORAL40% (100GM/250ML)YesYes
008ENTERO VU 24%BARIUM SULFATESUSPENSION;ORAL24% (144GM/600ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
32909-115Varibar Nectarbarium sulfateE-Z-EM Canada IncNDACurrent
32909-115Varibar Nectarbarium sulfateE-Z-EM Canada IncNDACurrent
32909-116Varibar Nectarbarium sulfateE-Z-EM Canada IncNDACurrent
32909-121Varibar Thin Honeybarium sulfateE-Z-EM Canada IncNDACurrent
32909-122Varibar Honeybarium sulfateE-Z-EM Canada IncNDACurrent
32909-145ENTERO Vu 24%barium sulfateE-Z-EM Canada IncNDACurrent
32909-145ENTERO Vu 24%barium sulfateE-Z-EM Canada IncNDACurrent
32909-146ENTERO Vu 24%barium sulfateE-Z-EM Canada IncNDACurrent
32909-146ENTERO Vu 24%barium sulfateE-Z-EM Canada IncNDACurrent
32909-186E-Z-Paquebarium sulfateE-Z-EM Canada IncNDACurrent
32909-186E-Z-Paquebarium sulfateE-Z-EM Canada IncNDACurrent
32909-187E-Z-Paquebarium sulfateE-Z-EM Canada IncNDACurrent
32909-711Readi-Cat 2 Berry SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-711Readi-Cat 2 Berry SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-722Readi-Cat 2 Banana SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-722Readi-Cat 2 Banana SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-724Readi-Cat 2Barium SulfateE-Z-EM Canada IncNDACurrent
32909-724Readi-Cat 2Barium SulfateE-Z-EM Canada IncNDACurrent
32909-741Readi-Cat 2 Berry SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-742Readi-Cat 2 Banana SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-744Readi-Cat 2Barium SulfateE-Z-EM Canada IncNDACurrent
32909-746Readi-Cat 2 Creamy Vanilla SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-747Readi-Cat 2 Mochaccino SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-756Readi-Cat 2 Creamy Vanilla SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-756Readi-Cat 2 Creamy Vanilla SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-777Readi-Cat 2 Mochaccino SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-777Readi-Cat 2 Mochaccino SmoothieBarium SulfateE-Z-EM Canada IncNDACurrent
32909-814Tagitol VBarium SulfateE-Z-EM Canada IncNDACurrent
32909-814Tagitol VBarium SulfateE-Z-EM Canada IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70523SUPPL2022-03-15
63383SUPPL2020-06-02
63375SUPPL2020-06-02
53518SUPPL2018-03-29
53454SUPPL2018-03-27
51902SUPPL2018-01-26
51858SUPPL2018-01-26
49283SUPPL2017-08-08
49274SUPPL2017-08-08
48947SUPPL2017-07-11
48935SUPPL2017-07-10
47463SUPPL2017-03-03
47389SUPPL2017-03-02
47158SUPPL2017-02-09
47147SUPPL2017-02-09
45863ORIG2016-11-09
19985ORIG2016-01-26
32894ORIG2016-01-20
62869ORIG1900-01-01
62868ORIG1900-01-01
62867ORIG1900-01-01
54030ORIG1900-01-01