PHPMaker 2020
Human Drugs
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Human Drugs
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Product Information
Registration Number
DR-XY47921
Generic Name
Peritoneal Dialysis Solution Low Calcium with 4.25% Dextrose
Brand Name
Dianeal PD-4
Dosage Strength
Dextrose hydrous, USP Sodium chloride, USP Sodium lactate, USP Calcium chloride dihydrate, USP Magnesium chloride hexahydrate, USP 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg
Dosage Form
Dialysis Solution
Classification
Prescription Drug (RX)
Pharmacologic Category
Peritoneal Dialytic
Packaging
2 L and 5 L PVC Twin bag Container in HDPE Overpouch
Manufacturer
Baxter Manufacturing (Thailand) Co., Ltd.
Country of Origin
Thailand
Trader
N/A
Importer
Vantive, Inc.
Distributor
N/A
Application Type
Initial (Variation
Issuance Date
24 August 2023
Expiry Date
24 August 2028
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