Details for New Drug Application (NDA): 077133

NDA 077133 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 077133

Tradename:	ADENOSINE
Applicant:	Fresenius Kabi Usa
Ingredient:	adenosine
Patents:	0

Pharmacology for NDA: 077133

Mechanism of Action

Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 077133

Analgesics

Anti-Arrhythmia Agents

Purinergic P1 Receptor Agonists

Vasodilator Agents

Suppliers and Packaging for NDA: 077133

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADENOSINE	adenosine	INJECTABLE;INJECTION	077133	ANDA	Henry Schein, Inc.	0404-9993	0404-9993-02	1 VIAL, SINGLE-USE in 1 BAG (0404-9993-02) / 2 mL in 1 VIAL, SINGLE-USE
ADENOSINE	adenosine	INJECTABLE;INJECTION	077133	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1450	51662-1450-3	10 POUCH in 1 CASE (51662-1450-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1450-2) / 4 mL in 1 VIAL, SINGLE-USE (51662-1450-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3MG/ML
Approval Date:	Apr 27, 2005	TE:	AP	RLD:	No

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