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ROCURONIUM BROMIDE

NDA

ROCURONIUM BROMIDE | N217472 | FRESENIUS KABI USA LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Citizen Petition from Lachman Consultant Services Inc. FDA-2021-P-0784 · 2 docket documents Lachman Consultant Services Inc. filed this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Rocuronium Bromide Injection, 20 mg/2 mL single dose prefilled syringe suitable for submission as an ANDA based on the reference listed drug ZEM	Suitability	2021-07-23	Open	Lachman Consultant Services Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

159 trials from ClinicalTrials.gov, 1 active, 112 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Deep Versus Moderate Muscle Relaxants in Men During and After Robotic Surgery for Prostate Cancer NCT03808077	Phase 2	Active	Memorial Sloan Kettering Cancer Center	139	2019-01-14 → 2027-01
Influence of Age, Sepsis and SLCO1A2 Polymorphisms on Rocuronium Pharmacokinetics NCT02399397	Phase 4	Completed	Universidade Estadual Paulista Júlio de Mesquita Filho	36	2014-02 → 2015-12
Remimazolam Phase II Cardiac Anesthesia Study NCT01937767	Phase 2	Completed	Paion UK Ltd.	90	2013-08 → 2014-02-19
Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population NCT02546843	N/A	Completed	Brno University Hospital	66	2015-12 → 2019-05
Neuromuscular Block and Anesthetic Depth Monitoring NCT02575443	N/A	Completed	Seoul National University Bundang Hospital	60	2015-09 → 2017-09
QLB After Nephrectomy NCT03529201	N/A	Completed	Medical University of Lublin	105	2018-05-07 → 2019-08-25
Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery NCT02079337	Phase 4	Completed	Herlev Hospital	14	2013-11 → 2014-04
Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis NCT02194855	Phase 4	Completed	Fudan University	100	2015-01-01 → 2016-06-01
Neuromuscular Blockade for Post-Cardiac Arrest Care NCT02260258	Phase 2	Completed	Beth Israel Deaconess Medical Center	83	2014-10 → 2019-05-29
Deep NMB in Ambulatory Gynecological Laparoscopy NCT04105764	Phase 4	Completed	Wahba bakhet	80	2016-12-01 → 2019-06-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain14 active DMFs3 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVROCURONIUM BROMIDE

DMF 98541992

WAVELENGTH ENTERPRISES LTDROCURONIUM BROMIDE

DMF 195722006

FARMHISPANIA SAROCURONIUM BROMIDE USP

DMF 198192006

TAPI NL BVROCURONIUM BROMIDE

DMF 200682006

GLAND PHARMA LTDROCURONIUM BROMIDE USP

DMF 208332007

GLAND CHEMICALS PRIVATE LTDROCURONIUM BROMIDE USP

DMF 264412012

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 267652012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDROCURONIUM BROMIDE USP

DMF 297412015

CHENGDU SINO-STRONG PHARMACEUTICAL CO LTDROCURONIUM BROMIDE

DMF 340572019

CURIA ITALY SRLROCURONIUM BROMIDE

DMF 342522019

SHANGHAI NEUTAN PHARMACEUTICAL CO LTDROCURONIUM BROMIDE INTERMEDIATE G (NEU1017-G)

DMF 366562022

SHANGHAI JUNMED HEALTHCARE CO LTDROCURONIUM BROMIDE (NEU1017-I)

DMF 376982023

MANKIND PHARMA LTDROCURONIUM BROMIDE USP

DMF 394372024

FARMHISPANIA SAROCURONIUM BROMIDE USP-PROCESS II

DMF 418942025

DR REDDYS LABORATORIES LTDInactiveROCURONIUM BROMIDE

DMF 208612007

RELIANCE LIFE SCIENCES PVT LTDInactiveROCURONIUM BROMIDE USP

DMF 251562011

AMRI ITALY SRLInactiveROCURONIUM BROMIDE

DMF 256222011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/5ML (10MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 9, 2025

No patent or exclusivity listings for this strength.

#002 — 100MG/10ML (10MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 9, 2025