APPLICATION
NDA018963
TYPE
NDA
ORIGINAL APPROVAL
1987-01-21
LATEST ACTION
2015-09-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CHOLETEC · ReferencePrescription
TECHNETIUM TC-99M MEBROFENIN KIT N/A · INJECTABLE · INJECTION
Approval history
2015-09-10Manufacturing (CMC) · Supplement 9 · standardAP
2007-09-19Manufacturing (CMC) · Supplement 6AP
2002-07-01Manufacturing (CMC) · Supplement 4 · standardAP
2000-05-19Manufacturing (CMC) · Supplement 3 · standardAP
1993-03-24Labeling · Supplement 2AP
1987-01-21Type 1 - New Molecular Entity · Original · standardAP
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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