APPLICATION
NDA018537
TYPE
NDA
ORIGINAL APPROVAL
1981-09-30
LATEST ACTION
2001-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRIDILDiscontinued
NITROGLYCERIN 5MG/ML · INJECTABLE · INJECTION
TRIDILDiscontinued
NITROGLYCERIN 0.5MG/ML · INJECTABLE · INJECTION
Approval history
2001-11-05Manufacturing (CMC) · Supplement 16 · priorityAP
1998-12-09Labeling · Supplement 15 · standardAP
1995-12-15Labeling · Supplement 13 · standardAP
1995-02-22Labeling · Supplement 12 · standardAP
1994-07-25Labeling · Supplement 11 · standardAP
1991-07-03Labeling · Supplement 10AP
1986-11-17Manufacturing (CMC) · Supplement 9 · priorityAP
1984-08-22Manufacturing (CMC) · Supplement 7 · priorityAP
1984-08-22Labeling · Supplement 8AP
1984-01-12Labeling · Supplement 4AP
1983-07-08Manufacturing (CMC) · Supplement 5 · priorityAP
1983-06-24Manufacturing (CMC) · Supplement 3 · priorityAP
1983-06-16Manufacturing (CMC) · Supplement 2 · priorityAP
1982-03-09Manufacturing (CMC) · Supplement 1 · priorityAP
1981-09-30Type 3 - New Dosage Form · 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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