Details for New Drug Application (NDA): 090212

NDA 090212 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 are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.

Summary for 090212

Tradename:	ADENOSINE
Applicant:	Mylan Asi
Ingredient:	adenosine
Patents:	0

Pharmacology for NDA: 090212

Mechanism of Action

Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 090212

Analgesics

Anti-Arrhythmia Agents

Purinergic P1 Receptor Agonists

Vasodilator Agents

Suppliers and Packaging for NDA: 090212

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	090212	ANDA	Mylan Institutional LLC	67457-856	67457-856-20	1 VIAL in 1 CARTON (67457-856-20) / 20 mL in 1 VIAL
ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	090212	ANDA	Mylan Institutional LLC	67457-857	67457-857-30	1 VIAL in 1 CARTON (67457-857-30) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	60MG/20ML (3MG/ML)
Approval Date:	Mar 28, 2014	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	90MG/30ML (3MG/ML)
Approval Date:	Mar 28, 2014	TE:	AP	RLD:	No

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