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SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE

NDA

SODIUM CHLORIDE | N019217 | ICU MEDICAL INC

4 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
APP Pharmaceuticals - Citizen Petition FDA-2009-P-0104 · 3 docket documents The provided document contains FDA electronic Orange Book listings for sodium chloride 0.9% injectable solution in plastic containers approved under three NDAs held by Hospira, but does not include the actual citizen petition text stating who filed it or what specific action was requested.	Other	2009-02-26	Withdrawn	—

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

Clinical Trials

222 trials from ClinicalTrials.gov — 5 recruiting, 5 active, 143 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine NCT04069897	Phase 3	Active	St. Olavs Hospital	170	2019-10-01 → 2026-06
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps NCT02134925	Phase 2	Active	National Cancer Institute (NCI)	110	2014-06-23 → 2027-03-09
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial NCT02261415	Phase 3	Active	Sunnybrook Health Sciences Centre	1,386	2014-11 → 2027-08
Intravenous Estrogen in Kidney Transplant Study NCT03663543	Phase 1/2	Active	University of Pennsylvania	30	2016-08-26 → 2027-05-01
Angiotensin-(1-7) and Energy Expenditure in Human Obesity NCT03777215	Early Phase 1	Active	Amy Arnold	30	2019-09-26 → 2026-12
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception NCT02691858	N/A	Recruiting	Cairo University	80	2015-04 → 2025-12
Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage NCT04043598	N/A	Recruiting	Insel Gruppe AG, University Hospital Bern	320	2022-05-24 → 2027-12
PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)NCT03559114	Phase 3	Recruiting	Sunnybrook Health Sciences Centre	1,100	2018-07-19 → 2027-12
Metabolic Effects of Angiotensin-(1-7)NCT02646475	Phase 1	Recruiting	Vanderbilt University	26	2016-02 → 2029-12
Lidocaine Infusion in Pancreatic Cancer NCT04048278	Early Phase 1	Recruiting	University of Illinois at Chicago	46	2018-11-08 → 2028-01-01

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

API Supply Chain5 active DMFs4 inactive

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

MARIAGER SALT SPECIALTIES A/SSODIUM CHLORIDE

DMF 221912010

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE BP (PARENTERAL GRADE)

DMF 231052009

NANDU CHEMICALS PVT LTDSODIUM CHLORIDE USP

DMF 284732014

VM CHEMICALSSODIUM CHLORIDE BP

DMF 290372015

EMNAR PHARMA PRIVATE LTDSODIUM CHLORIDE

DMF 414192025

CAMBRIDGE NUCLEAR RADIOPHARM CORPInactiveSODIUM CHLORIDE NA-24

DMF 22861974

ARES SERONO SAInactiveSODIUM CHLORIDE FOR INJECTION

DMF 100301993

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION 0.9% 4ML FILL IN A 5ML VIAL

DMF 156592001

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM CHLORIDE INJECTION USP 0.9%

DMF 215442008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 11, 2003	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 45MG/5ML (9MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Nov 18, 1998

#003 — 90MG/10ML (9MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Nov 18, 1998

#004 — 360MG/40ML (9MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Apr 1, 1999

#001 — 90MG/10ML (9MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INJECTION | Approved: Jul 13, 1984

No patent or exclusivity listings for this strength.