Orange Book product · Brand (NDA)
NIMBEX
CISATRACURIUM BESYLATE
At a glance
Dec 15, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 1995
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CISATRACURIUM BESYLATE
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020551
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024CISATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 216539 · HAINAN POLY
- 2024CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 216538 · HAINAN POLY
- 2023CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 217725 · CAPLIN
- 2023CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 203079 · HIKMA
- 2022CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 203078 · HIKMA
- 2022CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 215516 · GLAND
- 2022CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 212432 · PIRAMAL
- 2020CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 201836 · SAGENT PHARMS INC
- 2020CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 201851 · SAGENT PHARMS INC
- 2020CISATRACURIUM BESYLATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 209665 · EUGIA PHARMA
- 2020CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 213527 · ZYDUS PHARMS
- 2020CISATRACURIUM BESYLATEGeneric (ANDA)
ANDA 209144 · EUGIA PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

