Application 019367
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 002 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 003 | POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 004 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 005 | POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 006 | POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 007 | POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | No | No |
| 008 | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | INJECTABLE;INJECTION | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
| 0338-0811 | Potassium Chloride in Lactated Ringers and Dextrose | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84117 | SUPPL | 2025-11-06 |
| 84077 | SUPPL | 2025-11-06 |
| 60527 | SUPPL | 2020-01-23 |
| 60515 | SUPPL | 2019-10-10 |
| 50641 | SUPPL | 2017-12-07 |
| 50640 | SUPPL | 2017-12-07 |
| 11481 | SUPPL | 2011-11-04 |
| 1294 | SUPPL | 2011-10-24 |
| 33728 | SUPPL | 2005-08-31 |
| 1293 | SUPPL | 2005-08-31 |
| 17363 | SUPPL | 2005-06-08 |
| 11480 | SUPPL | 2005-06-08 |
| 17362 | SUPPL | 2003-01-03 |