ANDA 211968, held by Nephron. Sodium Chloride.
As of Nov 15, 2026, ANDA 211968 (Sodium Chloride 0.9% In Plastic Container), held by Nephron, was first approved by FDA on Apr 23, 2020, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2020 | Original application | Approved | None posted |
| Sodium Chloride 0.9% In Plastic Container450MG/50ML (9MG/ML) · solution;injection | Sodium Chloride | Rx |
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · solution;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
