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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 020201


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NDA 020201 describes DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Hospira 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. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.
Summary for 020201
Tradename:DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:Hospira
Ingredient:dobutamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020201
Mechanism of ActionAdrenergic beta-Agonists
Medical Subject Heading (MeSH) Categories for 020201
Suppliers and Packaging for NDA: 020201
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 020201 NDA Hospira, Inc. 0409-2346 0409-2346-32 12 POUCH in 1 CASE (0409-2346-32) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2346-31)
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER dobutamine hydrochloride INJECTABLE;INJECTION 020201 NDA Hospira, Inc. 0409-2347 0409-2347-32 12 POUCH in 1 CASE (0409-2347-32) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2347-31)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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