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Generated: April 23, 2017

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Details for New Drug Application (NDA): 083163

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NDA 083163 describes POTASSIUM CHLORIDE, which is a drug marketed by Lupin Ltd, Baxter Hlthcare, Abraxis Pharm, Actavis Labs Fl Inc, Hospira, Watson Labs, Kremers Urban Pharms, Lehigh Valley, Fresenius Kabi Usa, Copley Pharm, Pharma Res Software, Gd Searle Llc, Luitpold, Amneal Pharms, Novel Labs Inc, Sigmapharm Labs Llc, Teva, Schering, Tris Pharma Inc, Nesher Pharms, Pharmaceutics Intl, Pharma Serve Ny, Glenmark Pharms Ltd, Mylan Pharms Inc, Intl Medication, Adare Pharms Inc, Lilly, B Braun, Paddock Llc, Anchen Pharms, Akorn, Miles, and Icu Medcl, and is included in seventy-six NDAs. It is available from forty-eight 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 sixty-two drug master file entries for this compound. Three 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 NDA: 083163

Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2MEQ/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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