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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 207320

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NDA 207320 describes REGADENOSON, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Ge Healthcare, Gland, Hikma, Hospira, Ims Ltd, Indies Pharma, Meitheal, and Mylan, and is included in thirteen NDAs. It is available from sixteen suppliers. Additional details are available on the REGADENOSON profile page.

The generic ingredient in REGADENOSON is regadenoson. There are nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

Summary for 207320

Tradename:	REGADENOSON
Applicant:	Gland
Ingredient:	regadenoson
Patents:	0

Pharmacology for NDA: 207320

Mechanism of Action	Adenosine Receptor Agonists

Suppliers and Packaging for NDA: 207320

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207320	ANDA	Gland Pharma Limited	68083-175	68083-175-10	10 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01)
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207320	ANDA	Almaject, Inc.	72611-874	72611-874-10	10 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/5ML (0.08MG/ML)
Approval Date:	Jul 12, 2022	TE:	AP	RLD:	No

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