APPLICATION
NDA008719
TYPE
NDA
ORIGINAL APPROVAL
1953-01-08
LATEST ACTION
2000-12-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEVO-DROMORANDiscontinued
LEVORPHANOL TARTRATE 2MG/ML · INJECTABLE · INJECTION
Approval history
2000-12-05Manufacturing (CMC) · Supplement 32 · priorityAP
2000-04-24Manufacturing (CMC) · Supplement 31 · priorityAP
1999-07-13Manufacturing (CMC) · Supplement 30 · priorityAP
1998-01-26Manufacturing (CMC) · Supplement 29 · priorityAP
1994-08-15Manufacturing (CMC) · Supplement 27 · priorityAP
1994-08-15Manufacturing (CMC) · Supplement 28 · priorityAP
1991-12-19Efficacy · Supplement 8 · priorityAP
1989-09-27Manufacturing (CMC) · Supplement 26 · priorityAP
1989-03-09Manufacturing (CMC) · Supplement 25 · priorityAP
1985-10-23Manufacturing (CMC) · Supplement 23 · priorityAP
1985-09-03Manufacturing (CMC) · Supplement 24 · priorityAP
1985-02-26Manufacturing (CMC) · Supplement 22 · priorityAP
1984-06-07Labeling · Supplement 21 · priorityAP
1983-09-20Manufacturing (CMC) · Supplement 20 · priorityAP
1983-05-16Manufacturing (CMC) · Supplement 18 · priorityAP
1983-04-19Labeling · Supplement 19 · priorityAP
1982-03-03Manufacturing (CMC) · Supplement 17 · priorityAP
1981-09-08Manufacturing (CMC) · Supplement 16 · priorityAP
1981-02-27Manufacturing (CMC) · Supplement 14 · priorityAP
1978-11-15Manufacturing (CMC) · Supplement 11 · priorityAP
1978-02-07Manufacturing (CMC) · Supplement 10 · priorityAP
1953-01-08Type 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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