Application 020551
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIMBEX | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Yes | Yes |
| 002 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Yes | Yes |
| 003 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020551-001 | NIMBEX | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | |
| N020551-002 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | |
| N020551-003 | NIMBEX PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020551-001 | NIMBEX | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-12-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020551-002 | NIMBEX PRESERVATIVE FREE | EQ 10MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020551-003 | NIMBEX PRESERVATIVE FREE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020551-001 | NIMBEX | EQ 2MG BASE/ML | INJECTABLE / INJECTION | RLD | 1995-12-15 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020551-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020551-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020551-003 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020551-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020551-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020551-003 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020551-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020551-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020551-003 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020551-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020551-002 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020551-003 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020551-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020551-002 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020551-003 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020551-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020551-002 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020551-003 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020551-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020551-002 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020551-003 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020551-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020551-002 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020551-003 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020551-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020551-002 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020551-003 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020551-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020551-002 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020551-003 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020551-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020551-002 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020551-003 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020551-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020551-002 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020551-003 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020551-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020551-002 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020551-003 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020551-001 | AP | 1 | 6a51e52b5d6a… |
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 |
|---|---|---|---|---|---|---|
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Avenacy, LLC | 1c6a8b98-deac-4e25-b4a0-5d0af5090281 | 2026-06-30 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Hospira, Inc. | 67908e20-044d-454d-9c51-bf106e817bd0 | 2026-05-25 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Camber Pharmaceuticals Inc. | d8b5eb77-b393-4cd7-86c5-d2a9d131f96d | 2026-04-30 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Somerset Therapeutics, LLC | 23daa1f8-2a07-449d-97a6-11efdb0b9836 | 2026-04-29 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Somerset Therapeutics, LLC | ed91f65b-e002-43bd-bfa0-5ce8b89119e6 | 2026-04-29 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Eugia US LLC | 2cb05c7e-6228-4e2d-a270-7659e3db3fa7 | 2025-11-07 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Hikma Pharmaceuticals USA Inc. | c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6 | 2025-05-15 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Hikma Pharmaceuticals USA Inc. | 46c815f6-7a3d-43a3-b470-3377b126ba09 | 2025-05-15 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium besylate | CISATRACURIUM BESYLATE | Gland Pharma Limited | 0bacc37a-5e7f-4f05-9206-56fc8041c1ad | 2025-04-04 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium | CISATRACURIUM BESYLATE | Fresenius Kabi USA, LLC | f78a07e2-0d3b-4460-b29e-8c10c90afbda | 2025-02-21 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium besylate | CISATRACURIUM BESYLATE | Caplin Steriles Limited | 93101770-10a1-4bad-a762-289c793d8ace | 2025-01-17 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Armas Pharmaceuticals | dd078343-1f43-4405-8048-cf6c4f456549 | 2025-01-15 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| cisatracurium besylate | CISATRACURIUM BESYLATE | Sandoz Inc | 2ee0358e-2cce-40d3-9fcf-1b9088815c98 | 2024-10-31 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| cisatracurium besylate | CISATRACURIUM BESYLATE | Sandoz Inc | 291a55dd-ab45-4660-b513-4ecb729eb051 | 2024-10-31 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium besylate | CISATRACURIUM BESYLATE | Slate Run Pharmaceuticals, LLC | 49185e78-d244-4426-90ef-ad109824eddb | 2024-08-29 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| cisatracurium besylate | CISATRACURIUM BESYLATE | Zydus Pharmaceuticals USA Inc. | f9e1a84b-d19e-46c5-b40f-944ac1543dac | 2024-08-16 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium besylate | CISATRACURIUM BESYLATE | Slate Run Pharmaceuticals, LLC | e06c4d57-bfc7-45ad-b1cd-b5b88dc43b50 | 2024-03-25 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Meitheal Pharmaceuticals Inc. | 1be30efe-4beb-411a-bf82-6e4ea68fd262 | 2023-06-05 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| Cisatracurium Besylate | CISATRACURIUM BESYLATE | Meitheal Pharmaceuticals Inc. | 7c8c41b6-d07c-4740-84b7-603289104c59 | 2023-01-19 | Warnings, Adverse reactions | CISATRACURIUM BESYLATE |
| cisatracurium besylate | CISATRACURIUM BESYLATE | Zydus Lifesciences Limited | e145a40e-b046-4064-b35e-0da40ff3703e | 2022-11-05 | CISATRACURIUM BESYLATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4378 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4380 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
| 0074-4382 | Nimbex | Cisatracurium besylate | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72388 | SUPPL | 2022-10-17 |
| 72357 | SUPPL | 2022-10-17 |
| 72287 | SUPPL | 2022-10-11 |
| 55020 | SUPPL | 2018-10-24 |
| 55040 | SUPPL | 2018-07-30 |
| 55039 | SUPPL | 2018-07-30 |
| 55019 | SUPPL | 2018-07-27 |
| 2709 | SUPPL | 2010-11-30 |
| 34814 | SUPPL | 2010-11-22 |
| 25160 | SUPPL | 2010-06-08 |
| 25159 | SUPPL | 2003-07-28 |
| 2708 | SUPPL | 2002-06-04 |