ANDA 201833, held by Hikma. Sodium Chloride.
As of Nov 15, 2026, ANDA 201833 (Sodium Chloride 0.9%), held by Hikma, was first approved by FDA on Sep 24, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE This parenteral preparation indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2013 | Original application | Approved | None posted |
| Sodium Chloride 0.9%18MG/2ML (9MG/ML) · solution;injection | Sodium Chloride | Rx |
| Sodium Chloride 0.9%90MG/10ML (9MG/ML) · 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
