Application 018776
- Type
- NDA
- Sponsor
- ORGANON USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | NORCURON | VECURONIUM BROMIDE | INJECTABLE;INJECTION | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | NORCURON | VECURONIUM BROMIDE | INJECTABLE;INJECTION | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N018776-002 | NORCURON | VECURONIUM BROMIDE | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | |
| N018776-003 | NORCURON | VECURONIUM BROMIDE | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 |
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| 2026-02 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018776-002 | NORCURON | 10MG/VIAL | INJECTABLE / INJECTION | RLD | 1984-04-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018776-003 | NORCURON | 20MG/VIAL | INJECTABLE / INJECTION | RLD | 1992-01-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018776-002 | NORCURON | 10MG/VIAL | INJECTABLE / INJECTION | RLD | 1984-04-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018776-003 | NORCURON | 20MG/VIAL | INJECTABLE / INJECTION | RLD | 1992-01-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018776-002 | NORCURON | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1984-04-30 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018776-003 | NORCURON | 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1992-01-03 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| vecuronium bromide | VECURONIUM BROMIDE | Sun Pharmaceutical Industries, Inc. | a14da3ee-a731-4282-be9d-407473517470 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Phlow Corp. | b012b1b1-9e59-4525-8f4d-dae98344d15f | 2026-03-19 | Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Hikma Pharmaceuticals USA Inc. | dceeec01-2910-4489-8d70-9c0c711d17ab | 2026-01-29 | Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Mullan Pharmaceutical Inc. | aa35d139-25c8-4802-b165-0db7d1c08913 | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Meitheal Pharmaceuticals Inc. | 53653418-0464-4cd2-a987-3d31be36098f | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Eugia US LLC | 387b57ce-e50e-4e03-86d9-12638242bd36 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Sagent Pharmaceuticals | dff452e8-71e7-437e-bed0-3e1bd9441bc6 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | HF Acquisition Co LLC, DBA HealthFirst | e51c763e-2819-341f-e053-2995a90a0565 | 2024-02-22 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Eugia US LLC | 86d81719-534c-4e50-ae39-d8b20e50dfad | 2023-12-06 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| VECURONIUM BROMIDE | VECURONIUM BROMIDE | Mylan Institutional LLC | 96e69586-e9af-4b07-990f-12d93faa7edd | 2022-10-31 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |
| Vecuronium Bromide | VECURONIUM BROMIDE | Gland Pharma Limited | 5ae91612-4f65-4e52-8901-c37010612eaf | 2018-07-16 | Boxed warning, Warnings, Adverse reactions | VECURONIUM BROMIDE |