Application 204918
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) | No | No |
| 002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204918-001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | ||
| A204918-002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 |
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 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 79d66fd596c7… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204918-001 | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204918-002 | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE / INJECTION | 2024-07-12 | 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 |
|---|---|---|---|---|---|---|
| rocuronium bromide | ROCURONIUM BROMIDE | XGen Pharmaceuticals DJB, Inc. | b73f192c-2912-4ec3-9b4f-05a58d9b35ba | 2022-12-02 | Warnings, Adverse reactions | rocuronium bromide ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Sandoz Inc | cb28d869-6510-4402-9462-f6bb25fa0fa8 | 2022-10-13 | Warnings, Adverse reactions | Rocuronium Bromide ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | HF Acquisition Co LLC, DBA HealthFirst | dc444a4b-16ea-568d-e053-2995a90a53a7 | 2022-04-09 | Warnings, Adverse reactions | ROCURONIUM BROMIDE ROCURONIUM BROMIDE |
| Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | 209a654d-f92d-4242-bfef-2dcc90a30d3f | 2022-01-18 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | HF Acquisition Co LLC, DBA HealthFirst | 818f7cc6-2c3f-1788-e053-2991aa0a4c6a | 2021-03-01 | Warnings, Adverse reactions | ROCURONIUM BROMIDE ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Baxter Healthcare Corporation | 31e15c3f-aefa-4379-b684-7707744fe40d | 2019-09-30 | Warnings, Adverse reactions | Rocuronium Bromide ROCURONIUM BROMIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.