Details for New Drug Application (NDA): 210766
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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 210766
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | potassium chloride |
Patents: | 0 |
Pharmacology for NDA: 210766
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 210766
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | SOLUTION;ORAL | 210766 | ANDA | Pharmaceutical Associates, Inc. | 0121-0841 | 0121-0841-15 | 10 TRAY in 1 CASE (0121-0841-15) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE |
POTASSIUM CHLORIDE | potassium chloride | SOLUTION;ORAL | 210766 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0948 | 0121-0948-16 | 473 mL in 1 BOTTLE (0121-0948-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 20MEQ/15ML | ||||
Approval Date: | Mar 29, 2019 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 40MEQ/15ML | ||||
Approval Date: | Mar 29, 2019 | TE: | AA | RLD: | No |
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