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Generated: November 21, 2018

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Details for New Drug Application (NDA): 022454

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NDA 022454 describes DATSCAN, which is a drug marketed by Ge Hlthcare Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DATSCAN profile page.

The generic ingredient in DATSCAN is ioflupane i-123. One supplier is listed for this compound. Additional details are available on the ioflupane i-123 profile page.
Summary for 022454
Tradename:DATSCAN
Applicant:Ge Hlthcare Inc
Ingredient:ioflupane i-123
Patents:0
Pharmacology for NDA: 022454
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 022454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DATSCAN ioflupane i-123 SOLUTION;INTRAVENOUS 022454 NDA Medi-Physics Inc. dba GE Healthcare. 17156-210 17156-210-01 1 VIAL, GLASS in 1 CONTAINER (17156-210-01) > 2.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5mCi/2.5ML (2mCi/ML)
Approval Date:Jan 14, 2011TE:RLD:Yes

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