Details for New Drug Application (NDA): 210921
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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 210921
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | potassium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210921
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 210921
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | TABLET, EXTENDED RELEASE;ORAL | 210921 | ANDA | Major Pharmaceuticals | 0904-7216 | 0904-7216-61 | 100 BLISTER PACK in 1 CARTON (0904-7216-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
POTASSIUM CHLORIDE | potassium chloride | TABLET, EXTENDED RELEASE;ORAL | 210921 | ANDA | A-S Medication Solutions | 50090-5335 | 50090-5335-0 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5335-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8MEQ | ||||
Approval Date: | Dec 19, 2018 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
Approval Date: | Dec 19, 2018 | TE: | AB2 | RLD: | No |
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