APPLICATION
NDA018202
TYPE
NDA
ORIGINAL APPROVAL
1980-10-29
LATEST ACTION
2003-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYTADRENDiscontinued
AMINOGLUTETHIMIDE 250MG · TABLET · ORAL
Approval history
2002-05-13Manufacturing (CMC) · Supplement 20 · priorityAP
2002-01-25Manufacturing (CMC) · Supplement 19 · priorityAP
2000-08-01Manufacturing (CMC) · Supplement 18 · priorityAP
1999-04-23Manufacturing (CMC) · Supplement 17 · priorityAP
1999-03-18Manufacturing (CMC) · Supplement 16 · priorityAP
1998-04-15Labeling · Supplement 15 · standardAP
1995-03-23Manufacturing (CMC) · Supplement 14 · priorityAP
1994-01-14Manufacturing (CMC) · Supplement 13 · priorityAP
1993-07-27Labeling · Supplement 11AP
1992-08-04Manufacturing (CMC) · Supplement 12 · priorityAP
1984-11-09Labeling · Supplement 8 · priorityAP
1984-08-16Manufacturing (CMC) · Supplement 6 · priorityAP
1984-08-14Manufacturing (CMC) · Supplement 9 · priorityAP
1981-12-02Manufacturing (CMC) · Supplement 4 · priorityAP
1981-12-02Labeling · Supplement 3AP
1980-10-29Type 1 - New Molecular Entity · Original · priorityAP
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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