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FDA ANDA · ANDA213792

IOFLUPANE I 123

ioflupane i-123

Sponsor: CURIUM

APPLICATION
ANDA213792
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-30
LATEST ACTION
2023-09-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

IOFLUPANE I-123Prescription
IOFLUPANE I-123 5mCi/2.5ML (2mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-09-12Labeling · Supplement 1 · standardAP
2022-03-30UNKNOWN · Original · standardLetterAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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