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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212183

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NDA 212183 describes POTASSIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Endo Operations, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal, Belcher, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus Pharms, Pharma Serve Ny, Watson Labs, Anda Repository, Apotex, Genus Lifesciences, Pharm Assoc, Sciegen Pharms Inc, Wes Pharma Inc, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Macleods Pharms Ltd, Mylan, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Icu Medical Inc, and Nexus, and is included in one hundred and thirty NDAs. It is available from seventy-seven suppliers. Additional details are available on the POTASSIUM CHLORIDE profile page.

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 212183

Tradename:	POTASSIUM CHLORIDE
Applicant:	Belcher
Ingredient:	potassium chloride
Patents:	0

Pharmacology for NDA: 212183

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 212183

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POTASSIUM CHLORIDE	potassium chloride	FOR SOLUTION;ORAL	212183	ANDA	BPI Labs LLC	54288-125	54288-125-10	100 POUCH in 1 CARTON (54288-125-10) / 1.58 g in 1 POUCH (54288-125-01)
POTASSIUM CHLORIDE	potassium chloride	FOR SOLUTION;ORAL	212183	ANDA	BPI Labs LLC	54288-125	54288-125-30	30 POUCH in 1 CARTON (54288-125-30) / 1.58 g in 1 POUCH (54288-125-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	20MEQ
Approval Date:	May 6, 2019	TE:	AA	RLD:	No

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