Sodium Chloride 0.9% In Plastic Container

ANDA 88912, held by Fresenius Kabi USA. Sodium Chloride.

As of Nov 15, 2026, ANDA 88912 (Sodium Chloride 0.9% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Jan 10, 1985, with 15 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1985
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jan 10, 1985	Original application	Approved	None posted

Products

4 strengths and forms


Sodium Chloride 0.9% In Plastic Container90MG/10ML (9MG/ML) · solution;injection	Sodium Chloride	Rx
Sodium Chloride 0.9% In Plastic Container180MG/20ML (9MG/ML) · solution;injection	Sodium Chloride	Rx
Sodium Chloride 0.9% In Plastic Container270MG/30ML (9MG/ML) · solution;injection	Sodium Chloride	Rx
Sodium Chloride 0.9% In Plastic Container18MG/2ML (9MG/ML) · solution;injection	Sodium Chloride	Rx

All 16 submissions, including labeling and manufacturing supplements


Aug 11, 2020	Supplement 31Labeling · Standard review	Approved	None posted
May 21, 2007	Supplement 24Manufacturing	Approved	None posted
May 13, 2002	Supplement 22Manufacturing	Approved	None posted
Jun 8, 1998	Supplement 21Manufacturing	Approved	None posted
Nov 15, 1994	Supplement 17Manufacturing	Approved	None posted
Nov 15, 1994	Supplement 16Manufacturing	Approved	None posted
Feb 2, 1993	Supplement 20Labeling	Approved	None posted
Nov 2, 1992	Supplement 19Labeling	Approved	None posted
Aug 11, 1992	Supplement 18Labeling	Approved	None posted
Sep 28, 1987	Supplement 12Manufacturing	Approved	None posted
Sep 28, 1987	Supplement 11Manufacturing	Approved	None posted
Jun 8, 1987	Supplement 10Manufacturing	Approved	None posted
Jan 14, 1986	Supplement 8Manufacturing	Approved	None posted
Nov 29, 1985	Supplement 5Manufacturing	Approved	None posted
Nov 29, 1985	Supplement 3Manufacturing	Approved	None posted
Jan 10, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88912
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