Sodium Chloride 0.9% In Plastic Container

ANDA 207956, held by Laboratorios Grifols. Sodium Chloride.

As of Nov 15, 2026, ANDA 207956 (Sodium Chloride 0.9% In Plastic Container), held by Laboratorios Grifols, was first approved by FDA on May 25, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: May 25, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 25, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection	Sodium Chloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 11, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jun 9, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 25, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207956
Drugs@FDA: Overview at FDA
Company: Laboratorios Grifols

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