FDA.reportPublic FDA data

CISATRACURIUM BESYLATE

Product NDC
57884-3061
11-digit product format
578843061
Labeler code
57884
Product ID
57884-3061_7f34a8ee-1ad6-816a-e053-2991aa0aa7c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Jiangsu Hengrui Medicine Co., Ltd.
Application
ANDA204960
Marketing category
ANDA
Marketing start
2017-01-27
Marketing end
0000-00-00
Substance
CISATRACURIUM BESYLATE
Active strength
2 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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…