Application 215061
- Type
- ANDA
- Sponsor
- HENGRUI PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 1.20944GM/2ML (604.72MG/ML) | No | No |
| 002 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 4.5354GM/7.5ML (604.72MG/ML) | No | No |
| 003 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 6.0472GM/10ML (604.72MG/ML) | No | No |
| 004 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 9.0708GM/15ML (604.72MG/ML) | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-001 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-002 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-003 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-004 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2022-11-17 | 3f0d92c62455… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-003 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215061-004 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-003 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215061-004 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-003 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215061-004 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215061-004 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-003 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215061-004 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-002 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-003 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215061-004 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-002 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-003 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215061-004 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-002 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-003 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215061-004 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-002 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-003 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215061-004 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-002 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-003 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215061-004 | AP | 1 | 3f0d92c62455… |
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 |
|---|---|---|---|---|---|---|
| Gadobutrol | GADOBUTROL | Fresenius Kabi USA, LLC | 007696d0-4b62-4937-9640-4ad619504df4 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 215061 ANDA215061 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72940 | ORIG | 2022-12-20 |