Application 208036
- Type
- NDA
- Sponsor
- BRACCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | E-Z-HD | BARIUM SULFATE | FOR SUSPENSION;ORAL | 98% (334GM/BOT) | Yes | Yes |
| 002 | E-Z-PAQUE | BARIUM SULFATE | FOR SUSPENSION;ORAL | 96% (169GM/BOT) | Yes | Yes |
| 003 | E-Z-CAT DRY | BARIUM SULFATE | FOR SUSPENSION;ORAL | 40% (9GM/POUCH) | Yes | No |
| 004 | VARIBAR THIN LIQUID | BARIUM SULFATE | FOR SUSPENSION;ORAL | 81% (120GM/BOT) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208036-001 | E-Z-HD | BARIUM SULFATE | 98% | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | |
| N208036-002 | E-Z-PAQUE | BARIUM SULFATE | 96% | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | |
| N208036-003 | E-Z-CAT DRY | BARIUM SULFATE | 40% | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | |
| N208036-004 | VARIBAR THIN LIQUID | BARIUM SULFATE | 81% | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 |
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.
| 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 | N208036-001 | E-Z-HD | 98% | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208036-002 | E-Z-PAQUE | 96% | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208036-003 | E-Z-CAT DRY | 40% | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208036-004 | VARIBAR THIN LIQUID | 81% | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208036-001 | E-Z-HD | 98% | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208036-002 | E-Z-PAQUE | 96% | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208036-003 | E-Z-CAT DRY | 40% | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208036-004 | VARIBAR THIN LIQUID | 81% | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208036-001 | E-Z-HD | 98% (334GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2016-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208036-002 | E-Z-PAQUE | 96% (169GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2017-04-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208036-003 | E-Z-CAT DRY | 40% (9GM/POUCH) | FOR SUSPENSION / ORAL | RLD | 2017-01-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208036-004 | VARIBAR THIN LIQUID | 81% (120GM/BOT) | FOR SUSPENSION / ORAL | RLD, RS | 2019-04-30 | d06236e962d9… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| E-Z-Paque | BARIUM SULFATE | E-Z-EM Canada Inc | 7225868a-4037-c96a-44e3-3326d36cbedc | 2026-04-15 | Warnings, Adverse reactions | 208036 NDA208036 32909-750 |
| Varibar Thin Liquid | BARIUM SULFATE | E-Z-EM Canada Inc | 59493c83-3941-cc84-cc37-a8696ae42873 | 2026-04-15 | Warnings, Adverse reactions | 208036 NDA208036 32909-105 |
| E-Z-HD | BARIUM SULFATE | E-Z-EM Canada Inc | a4330804-7179-472a-91cb-84bbd5079bb8 | 2026-04-15 | Warnings, Adverse reactions | 208036 NDA208036 32909-764 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 32909-105 | Varibar Thin Liquid | barium sulfate | E-Z-EM Canada Inc | NDA | Current |
| 32909-750 | E-Z-Paque | barium sulfate | E-Z-EM Canada Inc | NDA | Current |
| 32909-750 | E-Z-Paque | barium sulfate | E-Z-EM Canada Inc | NDA | Current |
| 32909-764 | E-Z-HD | barium sulfate | E-Z-EM Canada Inc | NDA | Current |
| 32909-764 | E-Z-HD | barium sulfate | E-Z-EM Canada Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58520 | SUPPL | 2019-05-02 |
| 58504 | SUPPL | 2019-05-01 |
| 48044 | SUPPL | 2017-04-14 |
| 47905 | SUPPL | 2017-04-10 |
| 47157 | SUPPL | 2017-02-09 |
| 47146 | SUPPL | 2017-02-09 |
| 46674 | SUPPL | 2017-01-05 |
| 46666 | SUPPL | 2017-01-04 |
| 46004 | ORIG | 2016-12-02 |
| 40614 | ORIG | 2016-01-12 |
| 32881 | ORIG | 2016-01-12 |
| 63225 | ORIG | 1900-01-01 |
| 51876 | ORIG | 1900-01-01 |