Details for New Drug Application (NDA): 019308
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NDA 019308 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Otsuka Icu Medcl and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 019308
| Tradename: | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | dextrose; potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 019308
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019308
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019308 | NDA | Baxter Healthcare Company | 0338-0803 | 0338-0803-04 | 1000 mL in 1 BAG (0338-0803-04) |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019308 | NDA | Baxter Healthcare Company | 0338-0803 | 0338-0803-04 | 1000 mL in 1 BAG (0338-0803-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;150MG/100ML;900MG/100ML | ||||
| Approval Date: | Apr 5, 1985 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;150MG/100ML;900MG/100ML | ||||
| Approval Date: | Apr 5, 1985 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;300MG/100ML;900MG/100ML | ||||
| Approval Date: | Apr 5, 1985 | TE: | RLD: | No | |||||
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