Details for New Drug Application (NDA): 080205
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The generic ingredient in POTASSIUM CHLORIDE is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
Summary for 080205
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Hospira |
Ingredient: | potassium chloride |
Patents: | 0 |
Pharmacology for NDA: 080205
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 080205
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | INJECTABLE;INJECTION | 080205 | ANDA | Henry Schein, Inc. | 0404-9937 | 0404-9937-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9937-10) / 1 mL in 1 VIAL, SINGLE-DOSE |
POTASSIUM CHLORIDE | potassium chloride | INJECTABLE;INJECTION | 080205 | ANDA | Hospira, Inc. | 0409-6635 | 0409-6635-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6635-01) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-6635-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MEQ/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 004
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.4MEQ/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
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