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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077425

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NDA 077425 describes ADENOSINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Norvium Bioscience, 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 twelve suppliers. Additional details are available on the ADENOSINE profile page.

The generic ingredient in ADENOSINE is adenosine. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the adenosine profile page.

Summary for 077425

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

Medical Subject Heading (MeSH) Categories for 077425

Analgesics
Anti-Arrhythmia Agents
Purinergic P1 Receptor Agonists
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/20ML (3MG/ML)
Approval Date:	Aug 29, 2013	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	90MG/30ML (3MG/ML)
Approval Date:	Aug 29, 2013	TE:	AP	RLD:	No

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