APPLICATION
NDA018141
TYPE
NDA
ORIGINAL APPROVAL
1979-06-26
LATEST ACTION
2007-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TECHNETIUM TC 99M MPI MDPDiscontinued
TECHNETIUM TC-99M MEDRONATE KIT N/A · INJECTABLE · INJECTION
TECHNETIUM TC 99M MPI MDPDiscontinued
TECHNETIUM TC-99M MEDRONATE KIT N/A · INJECTABLE · INJECTION
Approval history
2002-11-25Manufacturing (CMC) · Supplement 26 · standardAP
2001-04-10Manufacturing (CMC) · Supplement 25 · standardAP
2000-09-29Manufacturing (CMC) · Supplement 24 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 23 · standardAP
1994-04-12Manufacturing (CMC) · Supplement 22 · standardAP
1992-07-01Manufacturing (CMC) · Supplement 21 · standardAP
1989-06-12Manufacturing (CMC) · Supplement 1 · standardAP
1989-02-17Manufacturing (CMC) · Supplement 19 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 17 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 16 · standardAP
1988-10-31Labeling · Supplement 20AP
1986-04-23Manufacturing (CMC) · Supplement 11 · standardAP
1985-05-09Labeling · Supplement 8AP
1985-05-09Labeling · Supplement 9AP
1985-05-09Manufacturing (CMC) · Supplement 7 · standardAP
1985-01-30Manufacturing (CMC) · Supplement 13 · standardAP
1982-03-31Manufacturing (CMC) · Supplement 4 · standardAP
1981-02-09Labeling · Supplement 5AP
1980-11-06Manufacturing (CMC) · Supplement 6 · standardAP
1980-06-09Labeling · Supplement 3AP
1979-06-26Type 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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