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FDA ANDA · ANDA078809
KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI
Sponsor: CARDINAL HEALTH 414
APPLICATION
ANDA078809
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-28
LATEST ACTION
2016-01-10
ROUTE
PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TECHNETIUM TC 99M SESTAMIBIPrescription
TECHNETIUM TC-99M SESTAMIBI KIT N/A · INJECTABLE · INJECTION
Approval history
2016-01-10Labeling · Supplement 5 · standardAP
2009-04-28OriginalAP
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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