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Last Updated: July 16, 2024

Details for New Drug Application (NDA): 016694

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NDA 016694 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 five 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 016694
Applicant:Baxter Hlthcare
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 016694
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 016694 NDA Baxter Healthcare Corporation 0338-0023 0338-0023-02 250 mL in 1 BAG (0338-0023-02)
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 016694 NDA Baxter Healthcare Corporation 0338-0023 0338-0023-03 500 mL in 1 BAG (0338-0023-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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