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FDA NDA · NDA202153

RUBY-FILL

rubidium rb 82

Sponsor: JUBILANT

APPLICATION
NDA202153
TYPE
NDA
ORIGINAL APPROVAL
2016-09-30
LATEST ACTION
2019-04-26
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RUBY-FILLPrescription
RUBIDIUM CHLORIDE RB-82 N/A · SOLUTION · INTRAVENOUS

Approval history

2019-04-26Labeling · Supplement 12 · standardLabelAP
2016-09-30Type 5 - New Formulation or New Manufacturer · 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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