Cardioplegic In Plastic Container
ANDA 214623, held by Fresenius Kabi USA. Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride.
- First approved: Feb 18, 2022
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2022 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Cardioplegic In Plastic Container17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML · solution;perfusion, cardiac | Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride | Rx |
Identifiers
- Application
- ANDA 214623
- Drugs@FDA
- Overview at FDA
- Company
- Fresenius Kabi USA
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters