Application 019308
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 003 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML;900MG/100ML | No | No |
| 004 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;75MG/100ML;900MG/100ML | No | No |
| 005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML;900MG/100ML | No | No |
| 006 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;224MG/100ML;900MG/100ML | No | No |
| 007 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML;900MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0803 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |
| 0338-0807 | Potassium Chloride in Dextrose and Sodium Chloride | Potassium Chloride, Dextrose Monohydrate and Sodium Chloride | Baxter Healthcare Corporation | NDA | Current |