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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 207604

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NDA 207604 describes REGADENOSON, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Ims Ltd, Meitheal, and Mylan, and is included in eleven NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

Summary for 207604

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

Pharmacology for NDA: 207604

Mechanism of Action	Adenosine Receptor Agonists

Suppliers and Packaging for NDA: 207604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REGADENOSON	regadenoson	SOLUTION;INTRAVENOUS	207604	ANDA	Apotex Corp.	60505-6116	60505-6116-0	1 SYRINGE, PLASTIC in 1 CARTON (60505-6116-0) / 5 mL in 1 SYRINGE, PLASTIC

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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