Application 020161
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 745MG/100ML | Yes | No |
| 002 | POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 1.49GM/100ML | Yes | No |
| 003 | POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 2.24GM/100ML | Yes | No |
| 004 | POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 2.98GM/100ML | Yes | Yes |
| 005 | POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 14.9MG/ML | Yes | No |
| 006 | POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 29.8MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7074 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7074 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7074 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7075 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7075 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7075 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7076 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7076 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7077 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7077 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7077 | Potassium Chloride | POTASSIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0990-7074 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7074 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7074 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7074 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7075 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7075 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7075 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7075 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7075 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7077 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7077 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7077 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7077 | Potassium Chloride | POTASSIUM CHLORIDE | ICU Medical Inc. | NDA | Current |