APPLICATION
NDA017264
TYPE
NDA
ORIGINAL APPROVAL
1974-02-14
LATEST ACTION
1989-02-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TECHNETIUM TC-99M PENTETATE KITDiscontinued
TECHNETIUM TC-99M PENTETATE KIT N/A · INJECTABLE · INJECTION
Approval history
1989-02-17Manufacturing (CMC) · Supplement 25 · standardAP
1988-12-23Manufacturing (CMC) · Supplement 24 · standardAP
1982-10-08Labeling · Supplement 20 · standardAP
1982-09-27Labeling · Supplement 21 · standardAP
1980-08-15Labeling · Supplement 18 · standardAP
1979-09-13Labeling · Supplement 13 · standardAP
1979-09-13Labeling · Supplement 9 · standardAP
1979-09-13Manufacturing (CMC) · Supplement 11 · standardAP
1979-09-13Labeling · Supplement 14 · standardAP
1979-09-13Labeling · Supplement 12 · standardAP
1977-04-26Manufacturing (CMC) · Supplement 8 · standardAP
1976-04-26Manufacturing (CMC) · Supplement 5 · standardAP
1976-01-30Manufacturing (CMC) · Supplement 6 · standardAP
1975-09-19Manufacturing (CMC) · Supplement 2 · standardAP
1974-02-14Type 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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