Application 215304
- Type
- ANDA
- Sponsor
- JIANGSU HENGRUI MED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 1.8845GM/5ML (376.9MG/ML) | No | No |
| 002 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 3.769GM/10ML (376.9MG/ML) | No | No |
| 003 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 5.6535GM/15ML (376.9MG/ML) | No | No |
| 004 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 7.538GM/20ML (376.9MG/ML) | No | No |
| 005 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | SOLUTION;INTRAVENOUS | 37.69GM/100ML (376.9MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215304-001 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | ||
| A215304-002 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | ||
| A215304-003 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | ||
| A215304-004 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | ||
| A215304-005 | GADOTERATE MEGLUMINE | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | 2022-04-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-001 | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-002 | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-003 | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-004 | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-005 | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-04-15 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A215304-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215304-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215304-005 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215304-005 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215304-005 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-004 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215304-005 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215304-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215304-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215304-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215304-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215304-005 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215304-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215304-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215304-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215304-004 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215304-005 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215304-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215304-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215304-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215304-004 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215304-005 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| Gadoterate Meglumine | GADOTERATE MEGLUMINE | Fresenius Kabi USA, LLC | e0655aac-9508-4141-94f5-fcca6af1c41d | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 215304 ANDA215304 65219-082 65219-080 65219-084 65219-086 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65219-080 | Gadoterate Meglumine | gadoterate meglumine | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-082 | Gadoterate Meglumine | gadoterate meglumine | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-084 | Gadoterate Meglumine | gadoterate meglumine | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-086 | Gadoterate Meglumine | gadoterate meglumine | Fresenius Kabi USA, LLC | ANDA | Current |