Details for New Drug Application (NDA): 078446
✉ Email this page to a colleague
The generic ingredient in POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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 078446
Tradename: | POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
Applicant: | Icu Medical Inc |
Ingredient: | potassium chloride; sodium chloride |
Patents: | 0 |
Pharmacology for NDA: 078446
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 078446
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 078446 | ANDA | ICU Medical Inc. | 0990-9257 | 0990-9257-39 | 12 POUCH in 1 CASE (0990-9257-39) / 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;450MG/100ML | ||||
Approval Date: | Sep 10, 2008 | TE: | AP | RLD: | No |
Complete Access Available with Subscription