NDA 21569, held by Liebel-Flarsheim. Sodium Chloride.
As of Nov 14, 2026, NDA 21569 (Sodium Chloride 0.9% In Plastic Container), held by Liebel-Flarsheim, was first approved by FDA on Jul 27, 2006, with 5 approved supplements and 0 published complete response letters.
125 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat, Illumena, Illumena Néo, CT9000, CT9000 ADV, Optistat, Optivantage and Optistar Elite. For use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Sodium Chloride 0.9% In Plastic Container450MG/50ML (9MG/ML) · injectable;injection | Sodium Chloride | DiscontinuedReference drug |
| Sodium Chloride 0.9% In Plastic Container1.125GM/125ML (9MG/ML) · injectable;injection | Sodium Chloride | RxReference drug |
| Dec 29, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Jun 10, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 2, 2012 | Supplement 4Labeling · Standard review | Approved | |
| Oct 1, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Apr 25, 2008 | Supplement 2Labeling · Standard review | Approved | |
| Jul 27, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
