APPLICATION
NDA020035
TYPE
NDA
ORIGINAL APPROVAL
1990-06-18
LATEST ACTION
1999-12-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ERGAMISOLDiscontinued
LEVAMISOLE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
1999-12-20Labeling · Supplement 13 · priorityAP
1998-10-23Labeling · Supplement 11 · priorityAP
1998-07-16Manufacturing (CMC) · Supplement 12 · priorityAP
1998-05-27Manufacturing (CMC) · Supplement 10 · priorityAP
1996-02-16Labeling · Supplement 9 · priorityAP
1995-11-22Manufacturing (CMC) · Supplement 8 · priorityAP
1994-10-20Manufacturing (CMC) · Supplement 7 · priorityAP
1994-04-11Manufacturing (CMC) · Supplement 6 · priorityAP
1993-12-17Labeling · Supplement 5 · priorityAP
1992-12-14Manufacturing (CMC) · Supplement 4 · priorityAP
1992-05-26Labeling · Supplement 3 · priorityAP
1992-03-10Labeling · Supplement 2 · priorityAP
1990-06-18Type 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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