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Johnson and Johnson
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Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075503

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NDA 075503 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 seventy-seven 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.
Summary for 075503
Suppliers and Packaging for NDA: 075503
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 075503 ANDA Akorn, Inc. 17478-920 N 17478-920-19
BALANCED SALT calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate SOLUTION;IRRIGATION 075503 ANDA Akorn, Inc. 17478-921 E 17478-921-95

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:Sep 27, 2006TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Julphar
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