ANDA 206171, held by Spectra Mdcl Devices. Sodium Chloride.
As of Nov 15, 2026, ANDA 206171 (Sodium Chloride 0.9%), held by Spectra Mdcl Devices, was first approved by FDA on Jul 21, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATION AND USAGE This parenteral preparation is 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 |
|---|---|---|---|
| Jul 21, 2017 | Original application | Approved | None posted |
| Sodium Chloride 0.9%45MG/5ML (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
