Details for New Drug Application (NDA): 018629
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NDA 018629 describes DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ 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 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ 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 018629
| Tradename: | DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | dextrose; potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 018629
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 018629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 018629 | NDA | Baxter Healthcare Corporation | 0338-0603 | 0338-0603-03 | 500 mL in 1 BAG (0338-0603-03) |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 018629 | NDA | Baxter Healthcare Corporation | 0338-0603 | 0338-0603-03 | 500 mL in 1 BAG (0338-0603-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;75MG/100ML;330MG/100ML | ||||
| Approval Date: | Mar 23, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;150MG/100ML;330MG/100ML | ||||
| Approval Date: | Mar 23, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;224MG/100ML;330MG/100ML | ||||
| Approval Date: | Mar 23, 1982 | TE: | AP | RLD: | No | ||||
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