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TRACRIUM PRESERVATIVE FREE

NDA

ATRACURIUM BESYLATE | N018831 | HOSPIRA INC

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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Abbott Laboratories FDA-1995-P-0325 · 10 docket documents Abbott Laboratories submitted a citizen petition under Section 505(b)(2) and 21 CFR 314.55(d)(2) requesting ANDA status to allow submission of an abbreviated new drug application for Atracurium Besylate Injection in concentrations of 0.5 or 1.0 mg/ml in 100 ml flexible containers, with a proposed ch	Other	2017-03-30	Granted	Abbott Laboratories

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

Clinical Trials

23 trials from ClinicalTrials.gov, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery NCT02544282	Phase 4	Completed	GZA Ziekenhuizen Campus Sint-Augustinus	140	2014-04 → 2016-03
Peri -and Postoperative Drug Therapy Schedules for Morbidly Obese Patients NCT01097148	Phase 4	Completed	St. Antonius Hospital	20	2009-11 → 2010-04
Premedication Trial for Tracheal Intubation of the NEOnate NCT01490580	Phase 2/3	Completed	Centre Hospitalier Intercommunal Creteil	173	2012-05 → 2020-04-15
Study of Use of Paravertebral Blocks for Pain Relief in Video Assisted Lung Surgery NCT01621698	N/A	Completed	University Hospitals Bristol and Weston NHS Foundation Trust	100	2012-07 → 2014-07
Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery NCT03243500	Phase 4	Completed	Kasr El Aini Hospital	91	2015-05-01 → 2016-05-01
Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block NCT03803267	N/A	Completed	Mansoura University	68	2019-05-01 → 2020-04-01
Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA NCT02920905	Phase 3	Completed	Assiut University	75	2015-11 → 2017-04
Does Sugared or Sugar Free Chewing Gum Reduces Postoperative Ileus After Laparoscopic Cholecystectomy NCT02162134	N/A	Completed	Benazir Bhutto Hospital, Rawalpindi	90	2013-01 → 2014-02
Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index NCT02174913	N/A	Completed	Mahidol University	34	2014-05 → 2016-02
The Effects of Anesthetic Method on Cerebral Oxygen Saturation in Geriatric Patients Undergoing Transurethral Surgery NCT01147146	N/A	Completed	Yonsei University	64	2010-06 → 2010-12

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

API Supply Chain5 active DMFs3 inactive

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

FARMHISPANIA SAATRACURIUM BESYLATE USP

DMF 116071995

TAPI NL BVATRACURIUM BESYLATE

DMF 117421995

GLAND PHARMA LTDATRACURIUM BESYLATE USP

DMF 211892007

GLAND PHARMA LTDATRACURIUM BESYLATE USP [PROCESS-II]

DMF 296362015

SOLARA ACTIVE PHARMA SCIENCES LTDATRACURIUM BESYLATE USP

DMF 382382023

ABBOTT LABORATORIESInactiveATRACURIUM BESYLATE

DMF 111441994

QUIMICA ESTEROIDAL SA DE CVInactiveATRACURIUM BESYLATE

DMF 121201996

CF PHARMA LTDInactiveATRACURIUM BESYLATE

DMF 184442005

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

Products (2)

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#002 — 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 20, 1985

#001 — 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 23, 1983

No patent or exclusivity listings for this strength.