Is there a generic for Cisatracurium besylate?

Yes. The FDA Orange Book lists 26 approved generic (ANDA) applications for Cisatracurium besylate, referencing the brand NIMBEX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cisatracurium besylate?

NIMBEX (NDA 020551, ABBVIE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Cisatracurium besylate are approved?

Cisatracurium besylate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cisatracurium besylate

Cisatracurium besylate: 1 brand, 26 generics; first approved Dec 15, 1995; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 26 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

NIMBEXRLD

ABBVIENDA 02055119953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

Generic (ANDA) products (26)

Abbreviated applications

CISATRACURIUM BESYLATE PRESERVATIVE FREE
HAINAN POLYANDA 21653920242 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
HAINAN POLYANDA 2165382024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE
CAPLINANDA 21772520232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
HIKMAANDA 2030792023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
HIKMAANDA 20307820222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
GLANDANDA 21551620223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
PIRAMALANDA 21243220222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
SAGENT PHARMS INCANDA 20183620202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
SAGENT PHARMS INCANDA 2018512020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE PRESERVATIVE FREE
EUGIA PHARMAANDA 2096652020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE
ZYDUS PHARMSANDA 2135272020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE
EUGIA PHARMAANDA 2091442020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE
ZYDUS PHARMSANDA 21217120192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATERS
MEITHEALANDA 21166820192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATERS
MEITHEALANDA 2116692019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
SOMERSETANDA 2091322019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE PRESERVATIVE FREE
SOMERSET THERAPS LLCANDA 20679120192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
HOSPIRAANDA 20323620182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
HOSPIRAANDA 2032382018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

CISATRACURIUM BESYLATE

HENGRUI PHARMAANDA 20496020173 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

CISATRACURIUM BESYLATE
ACCORD HLTHCAREANDA 2058732017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE PRESERVATIVE FREE
ACCORD HLTHCAREANDA 20587220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Discontinued —
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued —
CISATRACURIUM BESYLATE
FRESENIUS KABI USAANDA 2031832015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE PRESERVATIVE FREE
FRESENIUS KABI USAANDA 20318220152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE
SANDOZ INCANDA 2001592012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
CISATRACURIUM BESYLATE PRESERVATIVE FREE
SANDOZ INCANDA 20015420122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Dec 15, 1995

31 yr 2 mo ago

Most recent approval

Aug 27, 2024

2 yr ago

Approvals span 1995–2024 across 27 FDA applications.

Brand (NDA) 14%

Generic (ANDA) 2696%

Cisatracurium besylate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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