APPLICATION
NDA016996
TYPE
NDA
ORIGINAL APPROVAL
1973-01-22
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYPERSTATDiscontinued
DIAZOXIDE 15MG/ML · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 12AP
2000-11-09Manufacturing (CMC) · Supplement 23 · priorityAP
1999-04-29Manufacturing (CMC) · Supplement 22 · priorityAP
1998-10-21Manufacturing (CMC) · Supplement 21 · priorityAP
1997-06-04Manufacturing (CMC) · Supplement 20 · priorityAP
1996-11-01Manufacturing (CMC) · Supplement 19 · priorityAP
1990-02-05Manufacturing (CMC) · Supplement 18 · priorityAP
1987-06-12Manufacturing (CMC) · Supplement 17 · priorityAP
1986-10-20Manufacturing (CMC) · Supplement 4 · priorityAP
1986-07-23Manufacturing (CMC) · Supplement 16 · priorityAP
1986-04-07Manufacturing (CMC) · Supplement 15 · priorityAP
1985-09-17Manufacturing (CMC) · Supplement 14 · priorityAP
1984-08-21Efficacy · Supplement 9AP
1984-08-13Manufacturing (CMC) · Supplement 13 · priorityAP
1983-01-07Labeling · Supplement 10AP
1982-10-08Labeling · Supplement 11AP
1981-04-20Efficacy · Supplement 6AP
1981-01-08Manufacturing (CMC) · Supplement 8 · priorityAP
1980-08-14Manufacturing (CMC) · Supplement 7 · priorityAP
1980-02-04Labeling · Supplement 2AP
1980-02-04Labeling · Supplement 5AP
1980-02-04Labeling · Supplement 3AP
1978-06-30Labeling · Supplement 1AP
1973-01-22Type 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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