APPLICATION
NDA017538
TYPE
NDA
ORIGINAL APPROVAL
1974-05-28
LATEST ACTION
2025-11-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TECHNESCAN PYP KITPrescription
TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A · INJECTABLE · INJECTION
Approval history
2013-11-25Manufacturing (CMC) · Supplement 18 · standardAP
2007-02-26Manufacturing (CMC) · Supplement 15AP
1998-04-08Manufacturing (CMC) · Supplement 14 · standardAP
1998-03-23Manufacturing (CMC) · Supplement 13 · standardAP
1989-01-30Efficacy · Supplement 11AP
1988-02-22Labeling · Supplement 12AP
1984-05-21Labeling · Supplement 10AP
1982-05-07Manufacturing (CMC) · Supplement 9 · standardAP
1978-11-09Labeling · Supplement 8AP
1978-11-09Labeling · Supplement 7AP
1977-08-23Manufacturing (CMC) · Supplement 6 · standardAP
1977-07-27Manufacturing (CMC) · Supplement 5 · standardAP
1977-01-11Labeling · Supplement 4AP
1976-01-13Manufacturing (CMC) · Supplement 2 · standardAP
1974-05-28Type 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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