Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076404

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NDA 076404 describes ADENOSINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Pharmobedient, Rising, Teva Pharms Usa, Wockhardt, Avet Lifesciences, Eugia Pharma, Hospira, Meitheal, and Mylan Asi, and is included in twenty-one NDAs. It is available from thirteen suppliers. Additional details are available on the ADENOSINE profile page.

The generic ingredient in ADENOSINE is adenosine. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.

Summary for 076404

Tradename:	ADENOSINE
Applicant:	Hikma
Ingredient:	adenosine
Patents:	0

Medical Subject Heading (MeSH) Categories for 076404

Analgesics
Anti-Arrhythmia Agents
Purinergic P1 Receptor Agonists
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3MG/ML
Approval Date:	Jun 16, 2004	TE:	AP	RLD:	No

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