APPLICATION
NDA017680
TYPE
NDA
ORIGINAL APPROVAL
1976-10-20
LATEST ACTION
2025-05-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PHOSPHOTECDiscontinued
TECHNETIUM TC-99M PYROPHOSPHATE KIT N/A · INJECTABLE · INJECTION
Approval history
1999-12-14Manufacturing (CMC) · Supplement 12 · standardAP
1994-03-21Manufacturing (CMC) · Supplement 11 · standardAP
1988-05-09Labeling · Supplement 10AP
1985-09-30Manufacturing (CMC) · Supplement 9 · standardAP
1983-05-06Labeling · Supplement 6AP
1982-08-30Labeling · Supplement 8AP
1982-02-04Labeling · Supplement 4AP
1982-02-04Labeling · Supplement 5AP
1978-04-17Labeling · Supplement 2AP
1977-07-14Labeling · Supplement 3AP
1976-12-20Manufacturing (CMC) · Supplement 1 · standardAP
1976-10-20Type 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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