APPLICATION
NDA017714
TYPE
NDA
ORIGINAL APPROVAL
1976-11-16
LATEST ACTION
2002-12-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AN-DTPADiscontinued
TECHNETIUM TC-99M PENTETATE KIT N/A · INJECTABLE · INJECTION
Approval history
2002-12-12Manufacturing (CMC) · Supplement 22 · standardAP
1997-05-27Manufacturing (CMC) · Supplement 20 · standardAP
1993-02-23Manufacturing (CMC) · Supplement 19 · standardAP
1986-04-02Manufacturing (CMC) · Supplement 18 · standardAP
1986-01-27Manufacturing (CMC) · Supplement 17 · standardAP
1985-08-02Manufacturing (CMC) · Supplement 16 · standardAP
1985-04-29Manufacturing (CMC) · Supplement 15 · standardAP
1984-03-23Manufacturing (CMC) · Supplement 12 · standardAP
1983-06-03Manufacturing (CMC) · Supplement 11 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 8 · standardAP
1979-03-07Manufacturing (CMC) · Supplement 4 · standardAP
1979-03-07Manufacturing (CMC) · Supplement 5 · standardAP
1979-03-07Labeling · Supplement 1AP
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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