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Details for New Drug Application (NDA): 017512

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NDA 017512 describes DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER profile page.

The generic ingredient in DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There are two hundred and fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.

Suppliers and Packaging for NDA: 017512

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate
SOLUTION;INTRAPERITONEAL 017512 NDA Baxter Healthcare Corporation 0941-0409 0941-0409-01 6000 mL in 1 BAG (0941-0409-01)
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate
SOLUTION;INTRAPERITONEAL 017512 NDA Baxter Healthcare Corporation 0941-0409 0941-0409-05 3000 mL in 1 BAG (0941-0409-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No


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