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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 fifty-four 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: 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 17478-920-19 1 BOTTLE, PLASTIC in 1 POUCH (17478-920-19) > 18 mL in 1 BOTTLE, PLASTIC
BALANCED SALT
calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate
SOLUTION;IRRIGATION 075503 ANDA Akorn, Inc. 17478-921 17478-921-95 1 BOTTLE, GLASS in 1 BOTTLE (17478-921-95) > 500 mL in 1 BOTTLE, GLASS

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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