Application 017634
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;150MG/100ML | Yes | No |
| 002 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;300MG/100ML | Yes | No |
| 003 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;224MG/100ML | Yes | No |
| 004 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;75MG/100ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0683 | Potassium Chloride in Dextrose | Potassium Chloride and Dextrose Monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0683 | Potassium Chloride in Dextrose | Potassium Chloride and Dextrose Monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0683 | Potassium Chloride in Dextrose | Potassium Chloride and Dextrose Monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0683 | Potassium Chloride in Dextrose | Potassium Chloride and Dextrose Monohydrate | Baxter Healthcare Corporation | NDA | Current |
| 0338-0683 | Potassium Chloride in Dextrose | Potassium Chloride and Dextrose Monohydrate | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59349 | SUPPL | 2019-07-16 |
| 59339 | SUPPL | 2019-07-16 |
| 48608 | SUPPL | 2017-05-31 |
| 48607 | SUPPL | 2017-05-31 |
| 48595 | SUPPL | 2017-05-31 |
| 48594 | SUPPL | 2017-05-31 |
| 33323 | SUPPL | 2015-01-09 |
| 13873 | SUPPL | 2014-12-24 |
| 33322 | SUPPL | 2005-08-31 |
| 669 | SUPPL | 2005-08-31 |
| 33321 | SUPPL | 2005-05-25 |
| 668 | SUPPL | 2005-05-25 |
| 13872 | SUPPL | 2004-06-02 |