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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213236

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NDA 213236 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 213236

Tradename:	REGADENOSON
Applicant:	Accord Hlthcare
Ingredient:	regadenoson
Patents:	0

Pharmacology for NDA: 213236

Mechanism of Action	Adenosine Receptor Agonists

Suppliers and Packaging for NDA: 213236

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	213236	ANDA	Accord Healthcare Inc.	16729-477	16729-477-31	5 mL in 1 SYRINGE, GLASS (16729-477-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/5ML (0.08MG/ML)
Approval Date:	Apr 11, 2022	TE:	AP	RLD:	No

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