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Last Updated: July 10, 2020

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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, Anchen Pharms, Glenmark Pharms Ltd, Lannett Co Inc, Lupin Ltd, Nesher Pharms, Novel Labs Inc, Paddock Llc, Prinston Inc, Strides Pharma, Teva, Tris Pharma Inc, Zydus Pharms, Amneal Pharms Llc, Belcher, Epic Pharma Llc, Pharma Res Software, Abraxis Pharm, Akorn, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Lilly, Luitpold, Miles, Pharma Serve Ny, Watson Labs, Apotex, Genus Lifesciences, Pharm Assoc, Amneal, Aurobindo Pharma Ltd, Copley Pharm, Granules Pharms, Mylan, PII, Schering, Sigmapharm Labs Llc, Vitruvias Therap, Yichang Humanwell, and Icu Medical Inc, and is included in ninety-eight NDAs. It is available from sixty 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
Formulation / Manufacturing:see details
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:RXDosage:FOR SOLUTION;ORALStrength20MEQ
Approval Date:May 6, 2019TE:AARLD:No

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