Application 017635
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | SOLUTION;IRRIGATION | 33MG/100ML;30MG/100ML;860MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-6140 | Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-6140 | Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0990-6140 | Ringers Irrigation | Sodium Chloride, Potassium Chloride, and Calcium Chloride Irrigant | ICU Medical Inc. | NDA | Current |
| 0990-6140 | Ringers Irrigation | Sodium Chloride, Potassium Chloride, and Calcium Chloride Irrigant | ICU Medical Inc. | NDA | Current |