ANDA 88911, held by Fresenius Kabi USA. Sodium Chloride.
As of Nov 15, 2026, ANDA 88911 (Bacteriostatic Sodium Chloride 0.9% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Feb 7, 1985, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE These parenteral preparations are 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. NOT FOR INHALATION.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 1985 | Original application | Approved | None posted |
| Bacteriostatic Sodium Chloride 0.9% In Plastic Container270MG/30ML (9MG/ML) · solution;injection | Sodium Chloride | Rx |
| Bacteriostatic Sodium Chloride 0.9% In Plastic Container90MG/10ML (9MG/ML) · solution;injection | Sodium Chloride | Rx |
| May 21, 2007 | Supplement 14Manufacturing | Approved | None posted |
| Jun 20, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Jan 8, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Jan 13, 1993 | Supplement 11Labeling | Approved | None posted |
| Apr 30, 1987 | Supplement 7Manufacturing | Approved | None posted |
| Oct 31, 1986 | Supplement 5Manufacturing | Approved | None posted |
| May 17, 1985 | Supplement 1Manufacturing | Approved | None posted |
| May 17, 1985 | Supplement 3Manufacturing | Approved | None posted |
| Feb 7, 1985 | 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
