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Last Updated: April 14, 2021

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Details for New Drug Application (NDA): 091387

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NDA 091387 describes BALANCED SALT, which is a drug marketed by Akorn and B Braun and is included in two NDAs. It is available from two suppliers. Additional details are available on the BALANCED SALT profile page.

The generic ingredient in BALANCED SALT is calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate. There are two hundred and eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate profile page.
Suppliers and Packaging for NDA: 091387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALANCED SALT calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate SOLUTION;IRRIGATION 091387 ANDA B. Braun Medical Inc. 0264-2514 0264-2514-10 12 BOTTLE, GLASS in 1 CASE (0264-2514-10) > 500 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML
Approval Date:Feb 3, 2010TE:ATRLD:No

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