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Details for New Drug Application (NDA): 019445

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NDA 019445 describes DEXTROSE 50% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Hospira and is included in five NDAs. It is available from seven suppliers. Additional details are available on the DEXTROSE 50% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 50% IN PLASTIC CONTAINER is dextrose. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dextrose profile page.

Summary for NDA: 019445

Tradename:
DEXTROSE 25%
Applicant:
Hospira
Ingredient:
dextrose
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019445

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 25%
dextrose
INJECTABLE;INJECTION 019445 NDA Hospira, Inc. 0409-1775 0409-1775-10 10 CARTON in 1 PACKAGE (0409-1775-10) > 1 SYRINGE, PLASTIC in 1 CARTON > 10 mL in 1 SYRINGE, PLASTIC
DEXTROSE 25%
dextrose
INJECTABLE;INJECTION 019445 NDA Hospira, Inc. 0409-6648 0409-6648-02 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6648-02) > 50 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/ML
Approval Date:Jun 3, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/ML
Approval Date:Nov 23, 1998TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/ML
Approval Date:Sep 3, 2014TE:RLD:No


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