FDA — authorised 15 December 1995
- Application: NDA020551
- Marketing authorisation holder: ABBVIE
- Local brand name: NIMBEX
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Nimbex in United States
FDA authorised Nimbex on 15 December 1995
Marketing authorisations
FDA — authorised 3 February 2012
- Application: ANDA200159
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 February 2012
- Application: ANDA200154
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 2015
- Application: ANDA203183
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 February 2015
- Application: ANDA203182
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 2017
- Application: ANDA204960
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA205873
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA205872
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 August 2017
- Application: ANDA209334
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 2018
- Application: ANDA203238
- Marketing authorisation holder: HOSPIRA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 2018
- Application: ANDA203236
- Marketing authorisation holder: HOSPIRA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 February 2019
- Application: ANDA206791
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA209132
- Marketing authorisation holder: SOMERSET
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 2019
- Application: ANDA211668
- Marketing authorisation holder: MEITHEAL
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 2019
- Application: ANDA211669
- Marketing authorisation holder: MEITHEAL
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 November 2019
- Application: ANDA212171
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA209144
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 September 2020
- Application: ANDA213527
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 October 2020
- Application: ANDA209665
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 November 2020
- Application: ANDA201851
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 November 2020
- Application: ANDA201836
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 March 2022
- Application: ANDA212432
- Marketing authorisation holder: PIRAMAL
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 2022
- Application: ANDA215516
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 28 June 2022
- Application: ANDA203078
- Marketing authorisation holder: HIKMA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA203079
- Marketing authorisation holder: HIKMA
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Nimbex, a generic version of a neuromuscular blocking agent, for marketing in the United States. The approval was granted to HIKMA on 2024-10-08 under the standard expedited pathway. Nimbex is indicated for use in surgical procedures to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.
FDA — authorised 9 June 2023
- Application: ANDA217725
- Marketing authorisation holder: CAPLIN
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 2024
- Application: ANDA216538
- Marketing authorisation holder: HAINAN POLY
- Local brand name: CISATRACURIUM BESYLATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 2024
- Application: ANDA216539
- Marketing authorisation holder: HAINAN POLY
- Local brand name: CISATRACURIUM BESYLATE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
Nimbex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Nimbex approved in United States?
Yes. FDA authorised it on 15 December 1995; FDA authorised it on 3 February 2012; FDA authorised it on 3 February 2012.
Who is the marketing authorisation holder for Nimbex in United States?
ABBVIE holds the US marketing authorisation.