Details for New Drug Application (NDA): 211665
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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 211665
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | potassium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211665
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 211665
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | SOLUTION;ORAL | 211665 | ANDA | Strides Pharma Science Limited | 64380-874 | 64380-874-01 | 3 TRAY in 1 CASE (64380-874-01) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (64380-874-91) |
POTASSIUM CHLORIDE | potassium chloride | SOLUTION;ORAL | 211665 | ANDA | Strides Pharma Science Limited | 64380-874 | 64380-874-02 | 5 TRAY in 1 CASE (64380-874-02) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (64380-874-91) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 40MEQ/15ML | ||||
Approval Date: | Nov 17, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 20MEQ/15ML | ||||
Approval Date: | Jan 16, 2024 | TE: | AA | RLD: | No |
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