APPLICATION
NDA020219
TYPE
NDA
ORIGINAL APPROVAL
1993-11-10
LATEST ACTION
2000-12-26
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
LIVOSTINDiscontinued
LEVOCABASTINE HYDROCHLORIDE EQ 0.05% BASE · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2000-12-26Manufacturing (CMC) · Supplement 9 · priorityAP
1999-02-23Manufacturing (CMC) · Supplement 7 · priorityAP
1998-12-02Manufacturing (CMC) · Supplement 6 · priorityAP
1997-04-30Manufacturing (CMC) · Supplement 5 · priorityAP
1996-08-14Labeling · Supplement 4 · standardAP
1996-06-10Efficacy · Supplement 3 · standardAP
1995-03-23Labeling · Supplement 2 · standardAP
1994-10-24Labeling · Supplement 1 · standardAP
1993-11-10Type 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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