Last Updated: September 24, 2026

Details for New Drug Application (NDA): 077283

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NDA 077283 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 077283

Tradename:	ADENOSINE
Applicant:	Gland Pharma Ltd
Ingredient:	adenosine
Patents:	0

Pharmacology for NDA: 077283

Mechanism of Action	Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 077283

Analgesics
Anti-Arrhythmia Agents
Purinergic P1 Receptor Agonists
Vasodilator Agents

Suppliers and Packaging for NDA: 077283

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADENOSINE	adenosine	INJECTABLE;INJECTION	077283	ANDA	Sagent Pharmaceuticals	25021-301	25021-301-67	10 SYRINGE in 1 CARTON (25021-301-67) / 2 mL in 1 SYRINGE
ADENOSINE	adenosine	INJECTABLE;INJECTION	077283	ANDA	Sagent Pharmaceuticals	25021-301	25021-301-68	10 SYRINGE in 1 CARTON (25021-301-68) / 4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3MG/ML
Approval Date:	Jun 14, 2007	TE:	AP	RLD:	No

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