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Details for New Drug Application (NDA): 085870

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NDA 085870 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, Pharma-med Inc, 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, Lilly, Adare Pharms Inc, B Braun, Paddock Llc, Anchen Pharms, Akorn, and Miles, and is included in seventy-five NDAs. It is available from forty-five 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 fifty-three 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: 085870

B Braun
potassium chloride
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes

Pharmacology for NDA: 085870

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 085870

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
potassium chloride
INJECTABLE;INJECTION 085870 ANDA B. Braun Medical Inc. 0264-1940 0264-1940-20 12 CONTAINER in 1 CASE (0264-1940-20) > 250 mL in 1 CONTAINER

Summary for product number 001

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

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