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SODIUM CHLORIDE 14.6%

NDA

SODIUM CHLORIDE | N018897 | HOSPIRA INC

3 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

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Fresenius Kabi USA LLC FDA-2021-P-0211 · 6 docket documents Fresenius Kabi USA, LLC filed a suitability petition pursuant to 21 CFR 314.93 and Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for Sodium Chloride Injection 23.4% in a pharmacy bulk package format with an increased total drug content from 100 mL to 200 mL in plastic	Suitability	2021-02-23	Withdrawn	Fresenius Kabi USA LLC
Citizens Petition from Fresenius Kabi USA, LLC FDA-2020-P-2304 · 5 docket documents Fresenius Kabi USA, LLC submitted this citizen petition under 21 CFR 314.161 requesting that the FDA determine whether Sodium Chloride 14.6% 50mEq/20mL in plastic containers under NDA 018897 (held by Hospira, Inc.) was withdrawn from the marketplace for reasons other than safety or efficacy, to perm	505(q)	2020-12-17	Granted	Fresenius Kabi USA, LLC
Citizen Petition from Fresenius Kabi USA FDA-2016-P-2568 · 3 docket documents Fresenius Kabi USA, LLC filed this citizen petition on August 31, 2016, requesting that the FDA designate Sodium Chloride in Plastic Container (2.5 mEq/mL) by Hospira (NDA 018897) as the reference listed drug to enable applicants to submit abbreviated new drug applications for this multi-source prod	Other	2016-08-31	Open	Fresenius Kabi USA

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
Mar 14, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 20, 1984

No patent or exclusivity listings for this strength.

#002 — 100MEQ/40ML (2.5MEQ/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 20, 1984

#003 — 400MEQ/100ML (4MEQ/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 18, 2020