Details for New Drug Application (NDA): 202128
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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 202128
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | potassium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202128
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202128
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 202128 | ANDA | AvPAK | 50268-671 | 50268-671-13 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-671-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-671-11) |
POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 202128 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-542 | 53746-542-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (53746-542-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
Approval Date: | Feb 22, 2013 | TE: | AB | RLD: | No |
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