Viewing data from:

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

NDA

DEXTROSE; SODIUM CHLORIDE | N016697 | BAXTER HEALTHCARE CORP

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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2016-P-1104 · 4 docket documents Gordon Johnston Regulatory Consultants LLC filed this citizen petition on March 30, 2016, requesting that the FDA designate Dextrose 2.5% and Sodium Chloride Injection 0.45% Injection in Plastic Container by Baxter Healthcare (NDA 016697) as a reference listed drug to enable applicants to submit abb	505(q)	2016-04-08	Granted	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.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC, 1 NC)

Lowest Price

$32.76

Highest Price

$32.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00338-0073-042.5%Dextrose and 0.45%Sodium CL Inj #2B1024X	$32.76	NC	Baxter Healthcare Corporation	09/16/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 23, 2019	SUPPL -98	View Letter (PDF)
Sep 12, 2013	SUPPL -96	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5GM/100ML;450MG/100ML

RLDAP

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.