APPLICATION
NDA019753
TYPE
NDA
ORIGINAL APPROVAL
1990-06-19
LATEST ACTION
1997-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ETHMOZINEDiscontinued
MORICIZINE HYDROCHLORIDE 250MG · TABLET · ORAL
ETHMOZINEDiscontinued
MORICIZINE HYDROCHLORIDE 300MG · TABLET · ORAL
ETHMOZINEDiscontinued
MORICIZINE HYDROCHLORIDE 200MG · TABLET · ORAL
Approval history
1997-05-27Labeling · Supplement 8 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 9 · priorityAP
1992-09-16Labeling · Supplement 5AP
1992-07-08Manufacturing (CMC) · Supplement 7 · priorityAP
1992-06-22Manufacturing (CMC) · Supplement 6 · priorityAP
1991-09-20Labeling · Supplement 3AP
1990-08-23Manufacturing (CMC) · Supplement 1 · priorityAP
1990-06-19Type 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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