Details for New Drug Application (NDA): 077425

NDA 077425 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 077425

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

Pharmacology for NDA: 077425

Mechanism of Action

Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 077425

Analgesics

Anti-Arrhythmia Agents

Purinergic P1 Receptor Agonists

Vasodilator Agents

Suppliers and Packaging for NDA: 077425

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077425	ANDA	Meitheal Pharmaceuticals Inc.	71288-207	71288-207-21	10 VIAL, SINGLE-USE in 1 CARTON (71288-207-21) / 20 mL in 1 VIAL, SINGLE-USE
ADENOSINE	adenosine	SOLUTION;INTRAVENOUS	077425	ANDA	Meitheal Pharmaceuticals Inc.	71288-208	71288-208-30	1 VIAL, SINGLE-USE in 1 CARTON (71288-208-30) / 30 mL in 1 VIAL, SINGLE-USE

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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