Application 017513
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STERILE WATER IN PLASTIC CONTAINER | STERILE WATER FOR IRRIGATION | LIQUID;IRRIGATION | 100% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-6139 | Sterile Water | water | Hospira, Inc. | NDA | Current |
| 0409-6139 | Sterile Water | water | Hospira, Inc. | NDA | Current |
| 0409-7139 | Sterile Water | water | Hospira, Inc. | NDA | Current |
| 0409-7139 | Sterile Water | water | Hospira, Inc. | NDA | Current |
| 0990-6139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-6139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-6139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-6139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-7139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-7139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-7139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |
| 0990-7139 | Sterile Water | water | ICU Medical Inc. | NDA | Current |