Details for New Drug Application (NDA): 019686
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NDA 019686 describes POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
Summary for 019686
| Tradename: | POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 019686
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019686 | NDA | ICU Medical Inc. | 0990-7115 | 0990-7115-09 | 12 POUCH in 1 CASE (0990-7115-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
| POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019686 | NDA | ICU Medical Inc. | 0990-7116 | 0990-7116-09 | 12 POUCH in 1 CASE (0990-7116-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 149MG/100ML;900MG/100ML | ||||
| Approval Date: | Oct 17, 1988 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 298MG/100ML;900MG/100ML | ||||
| Approval Date: | Oct 17, 1988 | TE: | AP | RLD: | No | ||||
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