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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022454

DATSCAN (IOFLUPANE I-123)
5mCi/2.5ML (2mCi/ML)
Marketing Status: Prescription
Active Ingredient: IOFLUPANE I-123
Proprietary Name: DATSCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5mCi/2.5ML (2mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022454
Product Number: 001
Approval Date: Jan 14, 2011
Applicant Holder Full Name: GE HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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