ANDA 201850, held by Hikma. Sodium Chloride.
As of Nov 15, 2026, ANDA 201850 (Sodium Chloride 0.9%), held by Hikma, was first approved by FDA on Jan 20, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 20, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Chloride 0.9%90MG/10ML (9MG/ML) ยท solution;injection | Sodium Chloride | Discontinued |
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
