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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 214395

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NDA 214395 describes POTASSIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Adare Pharms Inc, Amneal Pharms, Chartwell Molecular, Glenmark Pharms Ltd, Granules, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Padagis Us, Ph Health, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Ajenat Pharms, Amneal, Anda Repository, Epic Pharma Llc, Genus, Novitium Pharma, Rubicon Research, Abraxis Pharm, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Nexus, Pharma Serve Ny, Watson Labs, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Genus Lifesciences, Macleods Pharms Ltd, Pharm Assoc, Quagen, Sciegen Pharms, Taro, Wes Pharma Inc, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Copley Pharm, Guangzhou Novaken, Pharmobedient, Rising, Schering, Sigmapharm Labs Llc, Twi Pharms, Yichang Humanwell, Otsuka Icu Medcl, and Icu Medical Inc, and is included in one hundred and thirty-seven NDAs. It is available from seventy-five suppliers. There is one patent protecting this drug. 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 214395

Tradename:	POTASSIUM CHLORIDE
Applicant:	Guangzhou Novaken
Ingredient:	potassium chloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MEQ
Approval Date:	Jan 28, 2021	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MEQ
Approval Date:	Jan 28, 2021	TE:	AB1	RLD:	No

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