APPLICATION
NDA017771
TYPE
NDA
ORIGINAL APPROVAL
1976-11-16
LATEST ACTION
2023-01-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
TECHNELITEDiscontinued
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 0.0083-2.7 CI/GENERATOR · SOLUTION · INTRAVENOUS
TECHNELITE · ReferencePrescription
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 1-20 CI/GENERATOR · SOLUTION · INTRAVENOUS
Approval history
2016-11-15Manufacturing (CMC) · Supplement 40 · standardAP
2016-02-12Manufacturing (CMC) · Supplement 38 · standardAP
2015-08-27Manufacturing (CMC) · Supplement 39 · standardAP
2015-02-09Manufacturing (CMC) · Supplement 36 · standardAP
2012-11-16Manufacturing (CMC) · Supplement 34 · standardAP
2009-03-25Manufacturing (CMC) · Supplement 25 · standardAP
2007-12-07Manufacturing (CMC) · Supplement 24 · standardAP
2004-09-02Manufacturing (CMC) · Supplement 23 · standardAP
2001-12-05Manufacturing (CMC) · Supplement 22 · standardAP
2000-12-06Manufacturing (CMC) · Supplement 21 · standardAP
2000-08-11Labeling · Supplement 19 · standardAP
2000-02-29Manufacturing (CMC) · Supplement 20 · standardAP
1998-02-04Manufacturing (CMC) · Supplement 18 · standardAP
1997-12-15Manufacturing (CMC) · Supplement 17 · standardAP
1997-11-05Manufacturing (CMC) · Supplement 16 · standardAP
1996-04-05Manufacturing (CMC) · Supplement 15 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 14 · standardAP
1996-01-11Manufacturing (CMC) · Supplement 13 · standardAP
1995-05-23Manufacturing (CMC) · Supplement 12 · standardAP
1993-08-12Manufacturing (CMC) · Supplement 11 · standardAP
1993-01-12Manufacturing (CMC) · Supplement 10 · standardAP
1985-04-29Labeling · Supplement 9AP
1983-05-13Manufacturing (CMC) · Supplement 8 · standardAP
1983-04-18Manufacturing (CMC) · Supplement 7 · standardAP
1978-11-21Labeling · Supplement 5AP
1978-10-11Manufacturing (CMC) · Supplement 1 · standardAP
1978-06-07Manufacturing (CMC) · Supplement 2 · standardAP
1976-11-16Type 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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