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SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER

NDA

SODIUM CHLORIDE | N019329 | ABRAXIS PHARMACEUTICAL PRODUCTS

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 - Amendment to Suitability Petition from Fresenius Kabi USA, LLC FDA-2018-P-4281 Fresenius Kabi USA, LLC submitted an amendment to a suitability petition on November 7, 2018, regarding Sodium Chloride Injection, USP, 23.4% under NDA 019329, which is the approved reference listed drug originally developed by Abraxis Pharmaceutical Products. The petition seeks FDA confirmation reg	Suitability	2020-06-24	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.

Products (1)

#001 — 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 22, 1987

No patent or exclusivity listings for this strength.