ANDA 78177, held by Fresenius Medcl. Sodium Chloride.
As of Nov 15, 2026, ANDA 78177 (Sodium Chloride 0.9% In Plastic Container), held by Fresenius Medcl, was first approved by FDA on Apr 12, 2007, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9% In Plastic Container900MG/100ML · injectable;injection | Sodium Chloride | Rx |
| Jun 2, 2009 | Supplement 5Labeling | Approved | None posted |
| Sep 22, 2008 | Supplement 3Labeling | Approved | None posted |
| Apr 12, 2007 | Original application | Approved | None posted |
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
