ANDA 209476, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 209476 (Sodium Chloride 3% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Mar 13, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: 3% Sodium Chloride Injection is indicated as a source of water and electrolytes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 3% In Plastic Container3GM/100ML · injectable;injection | Sodium Chloride | Rx |
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
