APPLICATION
NDA018321
TYPE
NDA
ORIGINAL APPROVAL
1981-02-18
LATEST ACTION
2025-11-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TECHNESCAN HDP · ReferencePrescription
TECHNETIUM TC-99M OXIDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
2014-06-17Manufacturing (CMC) · Supplement 21 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 20 · standardAP
1998-04-08Manufacturing (CMC) · Supplement 16 · standardAP
1996-02-29Manufacturing (CMC) · Supplement 5 · standardAP
1994-07-14Labeling · Supplement 15 · standardAP
1989-04-28Efficacy · Supplement 8AP
1988-09-30Manufacturing (CMC) · Supplement 14 · standardAP
1987-11-05Manufacturing (CMC) · Supplement 13 · standardAP
1986-01-10Manufacturing (CMC) · Supplement 10 · standardAP
1983-02-03Manufacturing (CMC) · Supplement 6 · standardAP
1981-02-18Type 5 - New Formulation or New Manufacturer · 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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