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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 074086


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NDA 074086 describes DOBUTAMINE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hospira, Luitpold, Slate Run Pharma, Teligent, Teva Parenteral, Watson Labs, and Watson Labs Inc, and is included in fifteen NDAs. It is available from five suppliers. Additional details are available on the DOBUTAMINE HYDROCHLORIDE profile page.

The generic ingredient in DOBUTAMINE HYDROCHLORIDE 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 074086
Tradename:DOBUTAMINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:dobutamine hydrochloride
Patents:0
Pharmacology for NDA: 074086
Mechanism of ActionAdrenergic beta-Agonists
Medical Subject Heading (MeSH) Categories for 074086
Suppliers and Packaging for NDA: 074086
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074086 ANDA Hospira, Inc. 0409-2344 0409-2344-88 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68)
DOBUTAMINE HYDROCHLORIDE dobutamine hydrochloride INJECTABLE;INJECTION 074086 ANDA Hospira, Inc. 0409-2344 0409-2344-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12.5MG BASE/ML
Approval Date:Nov 29, 1993TE:APRLD:No

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