Home Applications 201836 Application 201836
Type ANDA
Sponsor SAGENT PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML No No 002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201836-001 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 A201836-002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 2 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201836-001 CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201836-002 CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2020-11-06 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
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.
Matched openFDA labels page 1 of 1 · 19 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Camber Pharmaceuticals Inc. d8b5eb77-b393-4cd7-86c5-d2a9d131f96d 2026-04-30 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Somerset Therapeutics, LLC 23daa1f8-2a07-449d-97a6-11efdb0b9836 2026-04-29 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Somerset Therapeutics, LLC ed91f65b-e002-43bd-bfa0-5ce8b89119e6 2026-04-29 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Eugia US LLC 2cb05c7e-6228-4e2d-a270-7659e3db3fa7 2025-11-07 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Hikma Pharmaceuticals USA Inc. c5a63679-0c94-4e9d-9ac0-8ee3023bd9a6 2025-05-15 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Hikma Pharmaceuticals USA Inc. 46c815f6-7a3d-43a3-b470-3377b126ba09 2025-05-15 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium besylate CISATRACURIUM BESYLATE Gland Pharma Limited 0bacc37a-5e7f-4f05-9206-56fc8041c1ad 2025-04-04 Warnings, Adverse reactions Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE Cisatracurium CISATRACURIUM BESYLATE Fresenius Kabi USA, LLC f78a07e2-0d3b-4460-b29e-8c10c90afbda 2025-02-21 Warnings, Adverse reactions Name fallback generic name: CISATRACURIUM BESYLATE Cisatracurium besylate CISATRACURIUM BESYLATE Caplin Steriles Limited 93101770-10a1-4bad-a762-289c793d8ace 2025-01-17 Warnings, Adverse reactions Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Armas Pharmaceuticals dd078343-1f43-4405-8048-cf6c4f456549 2025-01-15 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE cisatracurium besylate CISATRACURIUM BESYLATE Sandoz Inc 2ee0358e-2cce-40d3-9fcf-1b9088815c98 2024-10-31 Warnings, Adverse reactions Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE cisatracurium besylate CISATRACURIUM BESYLATE Sandoz Inc 291a55dd-ab45-4660-b513-4ecb729eb051 2024-10-31 Warnings, Adverse reactions Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE Cisatracurium besylate CISATRACURIUM BESYLATE Slate Run Pharmaceuticals, LLC 49185e78-d244-4426-90ef-ad109824eddb 2024-08-29 Warnings, Adverse reactions Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE cisatracurium besylate CISATRACURIUM BESYLATE Zydus Pharmaceuticals USA Inc. f9e1a84b-d19e-46c5-b40f-944ac1543dac 2024-08-16 Warnings, Adverse reactions Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE Cisatracurium besylate CISATRACURIUM BESYLATE Slate Run Pharmaceuticals, LLC e06c4d57-bfc7-45ad-b1cd-b5b88dc43b50 2024-03-25 Warnings, Adverse reactions Name fallback brand name: Cisatracurium besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Meitheal Pharmaceuticals Inc. 1be30efe-4beb-411a-bf82-6e4ea68fd262 2023-06-05 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE Cisatracurium Besylate CISATRACURIUM BESYLATE Meitheal Pharmaceuticals Inc. 7c8c41b6-d07c-4740-84b7-603289104c59 2023-01-19 Warnings, Adverse reactions Name fallback brand name: Cisatracurium Besylate generic name: CISATRACURIUM BESYLATE cisatracurium besylate CISATRACURIUM BESYLATE Zydus Lifesciences Limited e145a40e-b046-4064-b35e-0da40ff3703e 2022-11-05 Name fallback brand name: cisatracurium besylate generic name: CISATRACURIUM BESYLATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25021-668 Cisatracurium Besylate cisatracurium besylate Sagent Pharmaceuticals ANDA Current 25021-668 Cisatracurium Besylate cisatracurium besylate Sagent Pharmaceuticals ANDA Current 25021-669 Cisatracurium Besylate cisatracurium besylate Sagent Pharmaceuticals ANDA Current 25021-669 Cisatracurium Besylate cisatracurium besylate Sagent Pharmaceuticals ANDA Current