ANDA 213688, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 213688 (Sodium Chloride 0.9% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Jun 24, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 0.9% Sodium Chloride Irrigation is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · solution;irrigation | 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
