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Details for New Drug Application (NDA): 021910

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NDA 021910 describes NORMOCARB HF 35, which is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug. Additional details are available on the NORMOCARB HF 35 profile page.

The generic ingredient in NORMOCARB HF 35 is magnesium chloride; sodium bicarbonate; sodium chloride. There are one hundred and twenty-eight drug master file entries for this compound. Additional details are available on the magnesium chloride; sodium bicarbonate; sodium chloride profile page.

Summary for NDA: 021910

Tradename:
NORMOCARB HF 25
Applicant:
Dialysis Sups
Ingredient:
magnesium chloride; sodium bicarbonate; sodium chloride
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength0.21GM/100ML;2.8GM/100ML;9.07GM/100ML
Approval Date:Jul 26, 2006TE:RLD:Yes
Patent:5,945,449Patent Expiration:Oct 31, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY
Patent:7,300,674Patent Expiration:Mar 4, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength0.21GM/100ML;3.97GM/100ML;8.3GM/100ML
Approval Date:Jul 26, 2006TE:RLD:Yes
Patent:5,945,449Patent Expiration:Oct 31, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY


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