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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 206778

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NDA 206778 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 206778

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

Pharmacology for NDA: 206778

Mechanism of Action	Adenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 206778

Analgesics
Anti-Arrhythmia Agents
Purinergic P1 Receptor Agonists
Vasodilator Agents

Suppliers and Packaging for NDA: 206778

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADENOSINE	adenosine	INJECTABLE;INJECTION	206778	ANDA	Sagent Pharmaceuticals	25021-318	25021-318-02	10 VIAL in 1 CARTON (25021-318-02) / 2 mL in 1 VIAL
ADENOSINE	adenosine	INJECTABLE;INJECTION	206778	ANDA	Sagent Pharmaceuticals	25021-318	25021-318-04	10 VIAL in 1 CARTON (25021-318-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3MG/ML
Approval Date:	Feb 16, 2018	TE:	AP	RLD:	No

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