APPLICATION
ANDA074811
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-30
LATEST ACTION
2011-09-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HALOPERIDOL DECANOATEDiscontinued
HALOPERIDOL DECANOATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2011-09-27Labeling · Supplement 17AP
2011-09-27Labeling · Supplement 15AP
2010-01-07Labeling · Supplement 13AP
2008-11-19Labeling · Supplement 12AP
2008-06-18Labeling · Supplement 11AP
2008-02-04Labeling · Supplement 10AP
2001-10-16Labeling · Supplement 1AP
2001-04-03Manufacturing (CMC) · Supplement 2AP
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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