Last Updated: September 24, 2026

Details for New Drug Application (NDA): 074277

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NDA 074277 describes DOBUTAMINE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hainan Poly, Hikma, Hospira, Luitpold, Teligent, Teva Parenteral, Watson Labs, and Watson Labs Inc, and is included in fifteen NDAs. It is available from four suppliers. Additional details are available on the DOBUTAMINE HYDROCHLORIDE profile page.

The generic ingredient in DOBUTAMINE HYDROCHLORIDE is dobutamine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.

Summary for 074277

Tradename:	DOBUTAMINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	dobutamine hydrochloride
Patents:	0

Pharmacology for NDA: 074277

Mechanism of Action	Adrenergic beta-Agonists

Medical Subject Heading (MeSH) Categories for 074277

Adrenergic beta-1 Receptor Agonists
Cardiotonic Agents
Sympathomimetics

Suppliers and Packaging for NDA: 074277

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOBUTAMINE HYDROCHLORIDE	dobutamine hydrochloride	INJECTABLE;INJECTION	074277	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9141	0143-9141-10	10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 12.5MG BASE/ML
Approval Date:	Oct 31, 1994	TE:	AP	RLD:	No

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