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Generated: April 21, 2019

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Details for New Drug Application (NDA): 209448

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NDA 209448 describes DEXTROSE 10% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Miles, and is included in eleven NDAs. It is available from four suppliers. Additional details are available on the DEXTROSE 10% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 10% IN PLASTIC CONTAINER is dextrose. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 209448
Tradename:DEXTROSE 10% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209448
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 209448 ANDA Fresenius Kabi USA, LLC 63323-824 63323-824-74 250 mL in 1 BAG (63323-824-74)
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 209448 ANDA Fresenius Kabi USA, LLC 63323-824 63323-824-75 500 mL in 1 BAG (63323-824-75)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Jul 16, 2018TE:APRLD:No

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