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Generated: November 20, 2018

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Details for New Drug Application (NDA): 207449

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NDA 207449 describes DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Icu Medical Inc, Hospira, B Braun, Miles, Abbott, DHL, and Fresenius Kabi Usa, and is included in forty-nine NDAs. It is available from seven suppliers. Additional details are available on the DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 207449
Tradename:DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 5% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 207449 ANDA Becton Dickinson and Company 17271-720 17271-720-03 100 mL in 1 BAG (17271-720-03)
DEXTROSE 5% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 207449 ANDA Becton Dickinson and Company 17271-720 17271-720-05 250 mL in 1 BAG (17271-720-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Oct 21, 2016TE:APRLD:No

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