Viewing data from:

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 (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Fresenius Kabi USA LLC FDA-2021-P-0211 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	Open	Fresenius Kabi USA LLC
Attachment 2- NDA 018897 RLD Labeling re: Suitability Petition from Fresenius... FDA-2021-P-0211 Fresenius Kabi USA LLC filed a suitability petition regarding NDA 018897, requesting FDA evaluation of the reference listed drug labeling to determine suitability for use as a reference standard for generic drug applications. The petition seeks confirmation that the existing labeling of this referen	Suitability	2021-02-23	Open	Fresenius Kabi USA LLC
Attachment A – Orange Book Listing of Sodium Chloride 14.6% - NDA 018897 RE C... FDA-2020-P-2304 Fresenius Kabi USA, LLC filed a citizen petition requesting that the FDA correct or review the Orange Book listing for Sodium Chloride 14.6% under NDA 018897, addressing apparent discrepancies in the drug's patent or exclusivity information maintained in the Orange Book database.	Other	2020-12-17	Open	Fresenius Kabi USA

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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