Application 215517
- Type
- ANDA
- Sponsor
- PIRAMAL CRITICAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | 0 | CISATRACURIUM BESYLATE | INJECTABLE;INJECTION | EQ 2MG BASE/ML | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A215517-001 | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE / INJECTION | AP | 2022-12-14 | 3bdfa0b2c4d7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215517-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215517-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215517-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215517-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215517-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215517-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215517-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A215517-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A215517-001 | AP | 1 | 3bdfa0b2c4d7… |
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 |