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SODIUM CHLORIDE 0.9%

NDA

SODIUM CHLORIDE | N202832 | MEDEFIL INC

6 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

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 Orange Book Listing of Sodium Chloride 0.9% Irrigation USP re Su... FDA-2019-P-6048 · 5 docket documents Fresenius Kabi USA, LLC filed a petition regarding the Orange Book listing of Sodium Chloride 0.9% Irrigation USP, challenging its suitability classification and requesting that the FDA reconsider or modify the regulatory status of this irrigation solution product in the Orange Book.	Suitability	2019-12-26	Open	Fresenius Kabi USA, LLC
Citizen Petition from Medefil Inc FDA-2018-P-3176 · 6 docket documents Medefil Inc. submitted this citizen petition on August 15, 2018, requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for its NDA 202832, Sodium Chloride Injection, USP, 0.9%, to designate the product as therapeutically equivalent to Hospira's NDA 01880	Other	2018-08-16	Denied	Medefil Inc
Foley & Lardner LLP - Citizen Petition FDA-2012-P-1043 · 3 docket documents Foley & Lardner LLP filed this citizen petition on behalf of Medefil's Inc. requesting that the FDA designate Sodium Chloride Injection, USP, 0.9% in prefilled plastic syringes, NDA 202832, as a second reference listed drug in the Orange Book to permit the filing of abbreviated new drug applications	505(q)	2012-10-04	Granted	—
Citizen Petition from Beckloff Associates FDA-2006-P-0084 · 6 docket documents Beckloff Associates filed a citizen petition regarding Hospira's Sodium Chloride 0.9% in Plastic Container (NDA 419217), an injectable solution approved on July 13, 1984, though the specific regulatory action requested is not detailed in the provided documentation excerpt.	Other	2009-03-18	Granted	Beckloff Associates

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

4 letters from Drugs@FDA

Date	Submission	Document
Oct 28, 2022	SUPPL -6	View Letter (PDF)
Dec 1, 2017	SUPPL -2	View Letter (PDF)
Oct 2, 2012	SUPPL -1	View Letter (PDF)
Jan 10, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — 9MG/ML (9MG/ML)

RLD

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