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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 016367


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NDA 016367 describes DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Icu Medical Inc, Hospira, B Braun, Miles, Abbott, Fresenius Kabi Usa, and DHL, 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 nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 016367
Tradename:DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 016367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 5% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 016367 NDA ICU Medical Inc. 0990-7922 0990-7922-02 24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG
DEXTROSE 5% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 016367 NDA ICU Medical Inc. 0990-7922 0990-7922-03 24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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