APPLICATION
NDA017454
TYPE
NDA
ORIGINAL APPROVAL
1973-09-28
LATEST ACTION
1980-01-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OSTEOSCANDiscontinued
TECHNETIUM TC-99M ETIDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
1980-01-09Manufacturing (CMC) · Supplement 20 · priorityAP
1979-07-17Manufacturing (CMC) · Supplement 16 · priorityAP
1979-07-17Manufacturing (CMC) · Supplement 15 · priorityAP
1979-03-23Manufacturing (CMC) · Supplement 14 · priorityAP
1979-01-25Manufacturing (CMC) · Supplement 19 · priorityAP
1978-08-02Efficacy · Supplement 18 · priorityAP
1978-02-24Labeling · Supplement 17 · priorityAP
1977-02-11Labeling · Supplement 13 · priorityAP
1977-02-11Manufacturing (CMC) · Supplement 12 · priorityAP
1977-01-27Manufacturing (CMC) · Supplement 11 · priorityAP
1977-01-22Manufacturing (CMC) · Supplement 10 · priorityAP
1976-03-04Labeling · Supplement 8 · priorityAP
1976-03-04Labeling · Supplement 9 · priorityAP
1976-03-04Manufacturing (CMC) · Supplement 7 · priorityAP
1975-05-21Manufacturing (CMC) · Supplement 6 · priorityAP
1973-09-28Type 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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