APPLICATION
NDA017684
TYPE
NDA
ORIGINAL APPROVAL
1976-11-19
LATEST ACTION
2000-05-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PYROLITEDiscontinued
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT N/A · INJECTABLE · INJECTION
Approval history
2000-05-02Manufacturing (CMC) · Supplement 19 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 18 · standardAP
1998-12-17Manufacturing (CMC) · Supplement 17 · standardAP
1998-03-23Manufacturing (CMC) · Supplement 16 · standardAP
1997-06-13Manufacturing (CMC) · Supplement 15 · standardAP
1989-06-26Labeling · Supplement 14 · standardAP
1989-05-02Manufacturing (CMC) · Supplement 13 · standardAP
1986-06-10Efficacy · Supplement 9 · standardAP
1983-11-17Manufacturing (CMC) · Supplement 8 · standardAP
1983-05-31Manufacturing (CMC) · Supplement 7 · standardAP
1983-03-02Efficacy · Supplement 1 · standardAP
1982-02-04Labeling · Supplement 6 · standardAP
1980-08-11Manufacturing (CMC) · Supplement 5 · standardAP
1976-11-19Type 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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