Application 204960

Type
ANDA
Sponsor
JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo
002CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo
003CISATRACURIUM BESYLATECISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-01-27
A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 10MG BASE/MLINJECTABLE / INJECTION2017-09-19
A204960-003CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-08-30

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 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2017-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-274b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204960-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204960-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204960-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204960-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204960-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204960-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204960-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204960-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204960-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204960-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204960-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204960-002AP174a2ff9319b5…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cisatracurium BesylateCISATRACURIUM BESYLATEAvenacy, LLC1c6a8b98-deac-4e25-b4a0-5d0af50902812026-06-30Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEHospira, Inc.67908e20-044d-454d-9c51-bf106e817bd02026-05-25Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATECamber Pharmaceuticals Inc.d8b5eb77-b393-4cd7-86c5-d2a9d131f96d2026-04-30Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATESomerset Therapeutics, LLC23daa1f8-2a07-449d-97a6-11efdb0b98362026-04-29Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATESomerset Therapeutics, LLCed91f65b-e002-43bd-bfa0-5ce8b89119e62026-04-29Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEEugia US LLC2cb05c7e-6228-4e2d-a270-7659e3db3fa72025-11-07Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.c5a63679-0c94-4e9d-9ac0-8ee3023bd9a62025-05-15Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEHikma Pharmaceuticals USA Inc.46c815f6-7a3d-43a3-b470-3377b126ba092025-05-15Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium besylateCISATRACURIUM BESYLATEGland Pharma Limited0bacc37a-5e7f-4f05-9206-56fc8041c1ad2025-04-04Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
CisatracuriumCISATRACURIUM BESYLATEFresenius Kabi USA, LLCf78a07e2-0d3b-4460-b29e-8c10c90afbda2025-02-21Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium besylateCISATRACURIUM BESYLATECaplin Steriles Limited93101770-10a1-4bad-a762-289c793d8ace2025-01-17Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEArmas Pharmaceuticalsdd078343-1f43-4405-8048-cf6c4f4565492025-01-15Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc2ee0358e-2cce-40d3-9fcf-1b9088815c982024-10-31Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc291a55dd-ab45-4660-b513-4ecb729eb0512024-10-31Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium besylateCISATRACURIUM BESYLATESlate Run Pharmaceuticals, LLC49185e78-d244-4426-90ef-ad109824eddb2024-08-29Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
cisatracurium besylateCISATRACURIUM BESYLATEZydus Pharmaceuticals USA Inc.f9e1a84b-d19e-46c5-b40f-944ac1543dac2024-08-16Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium besylateCISATRACURIUM BESYLATESlate Run Pharmaceuticals, LLCe06c4d57-bfc7-45ad-b1cd-b5b88dc43b502024-03-25Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEMeitheal Pharmaceuticals Inc.1be30efe-4beb-411a-bf82-6e4ea68fd2622023-06-05Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
Cisatracurium BesylateCISATRACURIUM BESYLATEMeitheal Pharmaceuticals Inc.7c8c41b6-d07c-4740-84b7-603289104c592023-01-19Warnings, Adverse reactionsName fallback
generic name: CISATRACURIUM BESYLATE
cisatracurium besylateCISATRACURIUM BESYLATEZydus Lifesciences Limitede145a40e-b046-4064-b35e-0da40ff3703e2022-11-05Name fallback
generic name: CISATRACURIUM BESYLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2033Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
0703-2045Cisatracurium BesylateCisatracurium BesylateTeva Parenteral Medicines, Inc.ANDACurrent
57884-3061CISATRACURIUM BESYLATECisatracurium besylateJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3063CISATRACURIUM BESYLATECisatracurium besylateJiangsu Hengrui Medicine Co., Ltd.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47056ORIG2017-01-31