Details for New Drug Application (NDA): 203002
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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 203002
Tradename: | POTASSIUM CHLORIDE |
Applicant: | Lupin Ltd |
Ingredient: | potassium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203002
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 203002
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 203002 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8212 | 0615-8212-05 | 15 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8212-05) |
POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 203002 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8212 | 0615-8212-39 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-8212-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 8MEQ | ||||
Approval Date: | Dec 18, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MEQ | ||||
Approval Date: | Dec 18, 2015 | TE: | AB | RLD: | No |
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