Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218054

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NDA 218054 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 thirteen suppliers. Additional details are available on the REGADENOSON profile page.

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

Summary for 218054

Tradename:	REGADENOSON
Applicant:	Indies Pharma
Ingredient:	regadenoson
Patents:	0

Pharmacology for NDA: 218054

Mechanism of Action	Adenosine Receptor Agonists

Suppliers and Packaging for NDA: 218054

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054	ANDA	Marlex Pharmaceuticals, Inc.	10135-803	10135-803-51	1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	218054	ANDA	Indies Pharma Jamaica Limited	83032-001	83032-001-02	1 SYRINGE in 1 CARTON (83032-001-02) / 5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/5ML (0.08MG/ML)
Approval Date:	Aug 22, 2024	TE:	AP	RLD:	No

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