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DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

NDA

DEXTROSE; SODIUM CHLORIDE | N017607 | OTSUKA ICU MEDICAL LLC

1 strength0 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
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2016-P-1106 · 4 docket documents Gordon Johnston Regulatory Consultants LLC filed this citizen petition requesting that the FDA designate Dextrose 5% and Sodium Chloride Injection 0.45% Injection in Plastic Container by Hospira (NDA 017607) as a reference listed drug pursuant to 21 CFR 314.94(a)(3), to enable applicants to submit a	505(q)	2016-04-08	Open	Gordon Johnston Regulatory Consultants LLC

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

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit NCT02863809	Phase 1/2	Completed	Joseph B. Ciolino, MD	76	2017-03-15 → 2021-08-31
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair NCT02752308	Phase 2/3	Completed	Isfahan University of Medical Sciences	60	2014-09 → 2015-03
Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2 NCT01836575	Phase 3	Completed	Instituto Nacional de Cancer, Brazil	228	2008-04 → 2012-12

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 17, 2018	SUPPL -123	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5GM/100ML;450MG/100ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.