APPLICATION
NDA017944
TYPE
NDA
ORIGINAL APPROVAL
1982-05-18
LATEST ACTION
2014-02-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MPI DMSA KIDNEY REAGENT · ReferenceDiscontinued
TECHNETIUM TC-99M SUCCIMER KIT N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2014-02-28Manufacturing (CMC) · Supplement 24 · standardAP
2013-11-22Manufacturing (CMC) · Supplement 23 · standardAP
2002-11-25Manufacturing (CMC) · Supplement 16 · standardAP
2001-04-10Manufacturing (CMC) · Supplement 15 · standardAP
2000-09-29Manufacturing (CMC) · Supplement 14 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 13 · standardAP
1995-11-16Manufacturing (CMC) · Supplement 12 · standardAP
1994-03-17Manufacturing (CMC) · Supplement 10 · standardAP
1993-07-15Manufacturing (CMC) · Supplement 11 · standardAP
1989-11-15Manufacturing (CMC) · Supplement 9 · standardAP
1989-02-17Manufacturing (CMC) · Supplement 6 · standardAP
1989-02-17Manufacturing (CMC) · Supplement 7 · standardAP
1986-04-10Manufacturing (CMC) · Supplement 1 · standardAP
1986-01-23Manufacturing (CMC) · Supplement 3 · standardAP
1985-03-12Labeling · Supplement 5AP
1985-01-30Manufacturing (CMC) · Supplement 4 · standardAP
1983-05-27Labeling · Supplement 2AP
1982-05-18Type 1 - New Molecular Entity · 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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