Application 217480
- Type
- ANDA
- Sponsor
- HAINAN POLY PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 4.5354GM/7.5ML (604.72MG/ML) | No | No |
| 002 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 9.0708GM/15ML (604.72MG/ML) | No | No |
| 003 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 1.20944GM/2ML (604.72MG/ML) | No | No |
| 004 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 6.0472GM/10ML (604.72MG/ML) | No | No |
| 005 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 18.1416GM/30ML (604.72MG/ML) | No | No |
| 006 | GADOBUTROL | GADOBUTROL | SOLUTION;INTRAVENOUS | 39.3068GM/65ML (604.72MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217480-001 | GADOBUTROL | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | |
| A217480-002 | GADOBUTROL | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | |
| A217480-003 | GADOBUTROL | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | |
| A217480-004 | GADOBUTROL | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | |
| A217480-005 | GADOBUTROL | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | |
| A217480-006 | GADOBUTROL | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217480-001 | AP |
| A217480-002 | AP |
| A217480-003 | AP |
| A217480-004 | AP |
| A217480-005 | AP |
| A217480-006 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217480-003 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217480-004 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217480-005 | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217480-006 | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-003 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-004 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-005 | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217480-006 | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-003 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-004 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-005 | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217480-006 | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-003 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-004 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-005 | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217480-006 | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-003 | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-004 | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-005 | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217480-006 | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217480-001 | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217480-002 | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-03-15 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217480-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217480-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217480-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217480-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217480-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217480-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217480-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217480-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217480-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217480-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217480-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217480-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217480-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217480-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217480-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217480-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217480-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217480-002 | AP | 1 | ea1830bbd6c7… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A217480-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A217480-002 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A217480-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A217480-002 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A217480-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A217480-002 | AP | 1 | 053a50430f4f… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-003 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-004 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-005 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217480-006 | AP | 1 | a50c72e98297… |
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 | Slate Run Pharmaceuticals, LLC | 52fbda34-9974-4f9f-9749-6b17d0495b62 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 217480 ANDA217480 |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 832e0ae1-4fe1-4dff-9978-c9200bcebb55 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 217480 ANDA217480 |
| gadobutrol | GADOBUTROL | Slate Run Pharmaceuticals, LLC | 4af6ee2b-d039-497f-a8f0-bdf948e5f54e | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 217480 ANDA217480 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.