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Details for New Drug Application (NDA): 022290

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NDA 022290 describes ADREVIEW, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the ADREVIEW profile page.

The generic ingredient in ADREVIEW is iobenguane sulfate i-123. One supplier is listed for this compound. Additional details are available on the iobenguane sulfate i-123 profile page.

Summary for NDA: 022290

Tradename:
ADREVIEW
Applicant:
Ge Healthcare
Ingredient:
iobenguane sulfate i-123
Patents:0

Suppliers and Packaging for NDA: 022290

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADREVIEW
iobenguane sulfate i-123
SOLUTION;INTRAVENOUS 022290 NDA Medi-Physics Inc. 17156-235 17156-235-01 1 VIAL, GLASS in 1 CONTAINER (17156-235-01) > 5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10mCi/5ML (2mCi/ML)
Approval Date:Sep 19, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 19, 2015
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 20, 2016
Regulatory Exclusivity Use:SCINTIGRAPIC ASSESSMENT OF SYMPATHETIC INNERVATION OF THE MYOCARDIUM BY MEASUREMENT OF THE HEART TO MEDIASTINUM (H/M) RATIO OF RADIOACTIVITY UPTAKE IN PATIENTS WITH NYHA CLASS II OR CLASS III HEART FAILURE AND LVEF LESS THAN 35%


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