Details for New Drug Application (NDA): 212346
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The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% 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 212346
Tradename: | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% |
Applicant: | Fresenius Kabi Usa |
Ingredient: | dextrose; potassium chloride |
Patents: | 0 |
Pharmacology for NDA: 212346
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 212346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | dextrose; potassium chloride | INJECTABLE;INJECTION | 212346 | ANDA | Fresenius Kabi USA, LLC | 63323-667 | 63323-667-10 | 10 BAG in 1 CASE (63323-667-10) / 1000 mL in 1 BAG (63323-667-01) |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | dextrose; potassium chloride | INJECTABLE;INJECTION | 212346 | ANDA | Fresenius Kabi USA, LLC | 63323-669 | 63323-669-10 | 10 BAG in 1 CASE (63323-669-10) / 1000 mL in 1 BAG (63323-669-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;75MG/100ML | ||||
Approval Date: | Sep 10, 2020 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;150MG/100ML | ||||
Approval Date: | Sep 10, 2020 | TE: | AP | RLD: | No |
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