Sodium Chloride 0.45% In Plastic Container

ANDA 208122, held by Fresenius Kabi USA. Sodium Chloride.

As of Nov 15, 2026, ANDA 208122 (Sodium Chloride 0.45% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Jul 23, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 23, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 23, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.45% In Plastic Container450MG/100ML · injectable;injection	Sodium Chloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 10, 2022	Supplement 11Manufacturing	Approved	None posted
Nov 30, 2020	Supplement 6Manufacturing	Approved	None posted
Nov 5, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jul 23, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 208122
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters