Application 020214
- Type
- NDA
- Sponsor
- ORGANON USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZEMURON | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | ZEMURON | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | ZEMURON | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020214-001 | ZEMURON | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | |
| N020214-002 | ZEMURON | ROCURONIUM BROMIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | |
| N020214-003 | ZEMURON | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 |
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 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020214-002 | ZEMURON | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020214-003 | ZEMURON | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020214-001 | ZEMURON | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-03-17 | 8072bd15b7f6… |
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 | Shandong New Time Pharmaceutical Co., Ltd. | f9f66e17-4850-47b6-bb2c-b9d126dffa68 | 2026-07-30 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | ProPharma Distribution | 579c4dfd-4877-33bb-e063-6394a90ae3d9 | 2026-07-27 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | B. Braun Medical Inc. | a54a79f7-5207-43d8-a139-7d57557caa50 | 2026-06-19 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Eugia US LLC | 116385ea-69fc-4f44-b463-6210291032df | 2026-05-14 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 4f9bf2d0-5702-4610-e063-6294a90a2cd9 | 2026-04-16 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Hospira, Inc. | cccd40ca-5f08-4acb-8548-3cad558388bb | 2026-04-15 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Hospira, Inc. | 309aeb1b-8022-4df7-8194-ae6529e3395c | 2026-03-09 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Meitheal Pharmaceuticals Inc. | b23aa80e-2af2-4a66-92ed-b1c8863be704 | 2026-01-09 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | ProPharma Distribution | 4304f145-24cb-dbe0-e063-6394a90a5dad | 2025-11-07 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | ProPharma Distribution | 42da65ee-2402-7b51-e063-6394a90a46b7 | 2025-11-05 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 41b1eb17-c0a4-cf60-e063-6394a90a67e6 | 2025-10-21 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Mylan Institutional LLC | f58803b0-f173-4997-b2f8-0f415b94dacf | 2025-08-15 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Civica, Inc. | 8ea475c7-d35e-47f4-8955-0df5ccd35b79 | 2025-07-28 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium | ROCURONIUM BROMIDE | Fresenius Kabi USA, LLC | 9a622308-7bda-4ca0-9de5-d6b3b4be3384 | 2025-07-16 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Lifestar Pharma LLC | 1141181f-3f62-4094-bfa2-454f89a14765 | 2025-06-03 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Solco Healthcare US, LLC | b7fba679-9c2d-4dac-af53-8c1331c966c3 | 2025-03-31 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | STERISCIENCE SPECIALTIES PRIVATE LIMITED | b894c436-ea67-407e-a801-f334a0c0c2d9 | 2025-01-21 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Gland Pharma Limited | a223a740-dbe8-4d06-8b8b-d9104b694e62 | 2025-01-08 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Caplin Steriles Limited | f1794318-b058-4254-97b7-d4e07126efbb | 2024-10-03 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
| Rocuronium Bromide | ROCURONIUM BROMIDE | Medical Purchasing Solutions, LLC | 15ea777f-2ba9-7f60-e063-6294a90a539b | 2024-04-12 | Warnings, Adverse reactions | ROCURONIUM BROMIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 55041 | SUPPL | 2018-07-30 |
| 55025 | SUPPL | 2018-07-27 |
| 34376 | SUPPL | 2015-01-08 |
| 2172 | SUPPL | 2015-01-08 |
| 2171 | SUPPL | 2010-11-30 |
| 34375 | SUPPL | 2010-11-22 |
| 24585 | SUPPL | 2008-08-29 |
| 12321 | SUPPL | 2008-08-29 |
| 52325 | SUPPL | 2008-04-03 |
| 24584 | SUPPL | 2004-08-25 |
| 24582 | SUPPL | 2004-03-03 |
| 24583 | SUPPL | 2003-06-08 |
| 52987 | SUPPL | 1900-01-01 |
| 52986 | SUPPL | 1900-01-01 |