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Details for New Drug Application (NDA): 020255

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NDA 020255 describes DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Hospira and Baxter Hlthcare and is included in two NDAs. It is available from three suppliers. Additional details are available on the DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER is dobutamine hydrochloride. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.

Summary for NDA: 020255

Pharmacology for NDA: 020255

Mechanism of ActionAdrenergic beta-Agonists

Suppliers and Packaging for NDA: 020255

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
dobutamine hydrochloride
INJECTABLE;INJECTION 020255 NDA Baxter Healthcare Corporation 0338-1073 0338-1073-02 18 BAG in 1 CARTON (0338-1073-02) > 250 mL in 1 BAG
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
dobutamine hydrochloride
INJECTABLE;INJECTION 020255 NDA Baxter Healthcare Corporation 0338-1075 0338-1075-02 18 BAG in 1 CARTON (0338-1075-02) > 250 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/100ML
Approval Date:Oct 19, 1993TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/100ML
Approval Date:Oct 19, 1993TE:APRLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/100ML
Approval Date:Oct 19, 1993TE:APRLD:Yes


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