APPLICATION
NDA018467
TYPE
NDA
ORIGINAL APPROVAL
1982-03-16
LATEST ACTION
2015-10-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEPATOLITEDiscontinued
TECHNETIUM TC-99M DISOFENIN KIT N/A · INJECTABLE · INJECTION
Approval history
2015-10-30Manufacturing (CMC) · Supplement 31 · priorityAP
2013-04-25Manufacturing (CMC) · Supplement 25 · priorityAP
2002-05-16Manufacturing (CMC) · Supplement 18 · priorityAP
2000-03-15Manufacturing (CMC) · Supplement 17 · priorityAP
2000-02-07Manufacturing (CMC) · Supplement 16 · priorityAP
1997-11-05Manufacturing (CMC) · Supplement 15 · priorityAP
1989-05-19Manufacturing (CMC) · Supplement 11 · priorityAP
1989-05-19Efficacy · Supplement 9AP
1989-05-19Manufacturing (CMC) · Supplement 7 · priorityAP
1989-05-19Labeling · Supplement 10AP
1989-05-02Manufacturing (CMC) · Supplement 12 · priorityAP
1986-02-28Manufacturing (CMC) · Supplement 5 · priorityAP
1983-06-07Labeling · Supplement 2AP
1983-04-26Manufacturing (CMC) · Supplement 1 · priorityAP
1983-04-21Manufacturing (CMC) · Supplement 3 · priorityAP
1982-03-16Type 1 - New Molecular Entity · Original · priorityAP
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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