APPLICATION
ANDA075305
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-28
LATEST ACTION
2023-04-26
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HALOPERIDOL DECANOATEPrescription
HALOPERIDOL DECANOATE EQ 100MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-26Labeling · Supplement 25 · standardAP
2019-06-18Manufacturing (CMC) · Supplement 22AP
2011-09-27Labeling · Supplement 17AP
2011-09-27Labeling · Supplement 15AP
2010-01-29Labeling · 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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