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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 209607

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NDA 209607 describes AZEDRA, which is a drug marketed by Progenics Pharms Inc and is included in one NDA. Additional details are available on the AZEDRA profile page.

The generic ingredient in AZEDRA is iobenguane i-131. Additional details are available on the iobenguane i-131 profile page.

Summary for 209607

Tradename:	AZEDRA
Applicant:	Progenics Pharms Inc
Ingredient:	iobenguane i-131
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	15mCi/ML
Approval Date:	Jul 30, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 30, 2025
Regulatory Exclusivity Use:	TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH IOBENGUANE SCAN POSITIVE, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC PHEOCHROMOCYTOMA OR PARAGANGLIOMA WHO REQUIRE SYSTEMIC ANTICANCER THERAPY

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