Home Applications 208143 Application 208143
Type NDA
Sponsor BRACCO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 READI-CAT 2 BARIUM SULFATE SUSPENSION;ORAL 2% (9GM/BOT) Yes Yes 002 READI-CAT 2 SMOOTHIE BARIUM SULFATE SUSPENSION;ORAL 2% (9GM/BOT) Yes Yes 003 LIQUID E-Z-PAQUE BARIUM SULFATE SUSPENSION;ORAL 60% (213GM/BOT) Yes Yes 004 VARIBAR NECTAR BARIUM SULFATE SUSPENSION;ORAL 40% (96GM/240ML) Yes Yes 005 TAGITOL V BARIUM SULFATE SUSPENSION;ORAL 40% (8GM/BOT) Yes Yes 006 VARIBAR THIN HONEY BARIUM SULFATE SUSPENSION;ORAL 40% (100GM/250ML) Yes Yes 007 VARIBAR HONEY BARIUM SULFATE SUSPENSION;ORAL 40% (100GM/250ML) Yes Yes 008 ENTERO VU 24% BARIUM SULFATE SUSPENSION;ORAL 24% (144GM/600ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208143-001 READI-CAT 2 BARIUM SULFATE 2% SUSPENSION / ORAL RLD, RS 2016-01-15 N208143-002 READI-CAT 2 SMOOTHIE BARIUM SULFATE 2% SUSPENSION / ORAL RLD, RS 2016-01-15 N208143-003 LIQUID E-Z-PAQUE BARIUM SULFATE 60% SUSPENSION / ORAL RLD, RS 2017-03-01 N208143-004 VARIBAR NECTAR BARIUM SULFATE 40% SUSPENSION / ORAL RLD, RS 2017-07-07 N208143-005 TAGITOL V BARIUM SULFATE 40% SUSPENSION / ORAL RLD, RS 2017-08-04 N208143-006 VARIBAR THIN HONEY BARIUM SULFATE 40% SUSPENSION / ORAL RLD, RS 2018-01-23 N208143-007 VARIBAR HONEY BARIUM SULFATE 40% SUSPENSION / ORAL RLD, RS 2018-03-26 N208143-008 ENTERO VU 24% BARIUM SULFATE 24% SUSPENSION / ORAL RLD, RS 2020-05-29
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 1 of 9 · 324 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208143-001 READI-CAT 2 2% SUSPENSION / ORAL RLD, RS 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-002 READI-CAT 2 SMOOTHIE 2% SUSPENSION / ORAL RLD, RS 2016-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-003 LIQUID E-Z-PAQUE 60% SUSPENSION / ORAL RLD, RS 2017-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-004 VARIBAR NECTAR 40% SUSPENSION / ORAL RLD, RS 2017-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-005 TAGITOL V 40% SUSPENSION / ORAL RLD, RS 2017-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-006 VARIBAR THIN HONEY 40% SUSPENSION / ORAL RLD, RS 2018-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-007 VARIBAR HONEY 40% SUSPENSION / ORAL RLD, RS 2018-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208143-008 ENTERO VU 24% 24% SUSPENSION / ORAL RLD, RS 2020-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-001 READI-CAT 2 2% SUSPENSION / ORAL RLD, RS 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-002 READI-CAT 2 SMOOTHIE 2% SUSPENSION / ORAL RLD, RS 2016-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-003 LIQUID E-Z-PAQUE 60% SUSPENSION / ORAL RLD, RS 2017-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-004 VARIBAR NECTAR 40% SUSPENSION / ORAL RLD, RS 2017-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-005 TAGITOL V 40% SUSPENSION / ORAL RLD, RS 2017-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-006 VARIBAR THIN HONEY 40% SUSPENSION / ORAL RLD, RS 2018-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-007 VARIBAR HONEY 40% SUSPENSION / ORAL RLD, RS 2018-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208143-008 ENTERO VU 24% 24% SUSPENSION / ORAL RLD, RS 2020-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208143-001 READI-CAT 2 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-002 READI-CAT 2 SMOOTHIE 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-003 LIQUID E-Z-PAQUE 60% (213GM/BOT) SUSPENSION / ORAL RLD, RS 2017-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-004 VARIBAR NECTAR 40% (96GM/240ML) SUSPENSION / ORAL RLD, RS 2017-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-005 TAGITOL V 40% (8GM/BOT) SUSPENSION / ORAL RLD, RS 2017-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-006 VARIBAR THIN HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-007 VARIBAR HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208143-008 ENTERO VU 24% 24% (144GM/600ML) SUSPENSION / ORAL RLD, RS 2020-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-001 READI-CAT 2 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-002 READI-CAT 2 SMOOTHIE 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-003 LIQUID E-Z-PAQUE 60% (213GM/BOT) SUSPENSION / ORAL RLD, RS 2017-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-004 VARIBAR NECTAR 40% (96GM/240ML) SUSPENSION / ORAL RLD, RS 2017-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-005 TAGITOL V 40% (8GM/BOT) SUSPENSION / ORAL RLD, RS 2017-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-006 VARIBAR THIN HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-007 VARIBAR HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208143-008 ENTERO VU 24% 24% (144GM/600ML) SUSPENSION / ORAL RLD, RS 2020-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-001 READI-CAT 2 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-002 READI-CAT 2 SMOOTHIE 2% (9GM/BOT) SUSPENSION / ORAL RLD, RS 2016-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-003 LIQUID E-Z-PAQUE 60% (213GM/BOT) SUSPENSION / ORAL RLD, RS 2017-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-004 VARIBAR NECTAR 40% (96GM/240ML) SUSPENSION / ORAL RLD, RS 2017-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-005 TAGITOL V 40% (8GM/BOT) SUSPENSION / ORAL RLD, RS 2017-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-006 VARIBAR THIN HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-007 VARIBAR HONEY 40% (100GM/250ML) SUSPENSION / ORAL RLD, RS 2018-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208143-008 ENTERO VU 24% 24% (144GM/600ML) SUSPENSION / ORAL RLD, RS 2020-05-29 b8a1b40f171c…
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 · 7 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 29 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 32909-115 Varibar Nectar barium sulfate E-Z-EM Canada Inc NDA Current 32909-115 Varibar Nectar barium sulfate E-Z-EM Canada Inc NDA Current 32909-116 Varibar Nectar barium sulfate E-Z-EM Canada Inc NDA Current 32909-121 Varibar Thin Honey barium sulfate E-Z-EM Canada Inc NDA Current 32909-122 Varibar Honey barium sulfate E-Z-EM Canada Inc NDA Current 32909-145 ENTERO Vu 24% barium sulfate E-Z-EM Canada Inc NDA Current 32909-145 ENTERO Vu 24% barium sulfate E-Z-EM Canada Inc NDA Current 32909-146 ENTERO Vu 24% barium sulfate E-Z-EM Canada Inc NDA Current 32909-146 ENTERO Vu 24% barium sulfate E-Z-EM Canada Inc NDA Current 32909-186 E-Z-Paque barium sulfate E-Z-EM Canada Inc NDA Current 32909-186 E-Z-Paque barium sulfate E-Z-EM Canada Inc NDA Current 32909-187 E-Z-Paque barium sulfate E-Z-EM Canada Inc NDA Current 32909-711 Readi-Cat 2 Berry Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-711 Readi-Cat 2 Berry Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-722 Readi-Cat 2 Banana Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-722 Readi-Cat 2 Banana Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-724 Readi-Cat 2 Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-724 Readi-Cat 2 Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-741 Readi-Cat 2 Berry Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-742 Readi-Cat 2 Banana Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-744 Readi-Cat 2 Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-746 Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-747 Readi-Cat 2 Mochaccino Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-756 Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-756 Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-777 Readi-Cat 2 Mochaccino Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-777 Readi-Cat 2 Mochaccino Smoothie Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-814 Tagitol V Barium Sulfate E-Z-EM Canada Inc NDA Current 32909-814 Tagitol V Barium Sulfate E-Z-EM Canada Inc NDA Current