APPLICATION
ANDA075393
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-11
LATEST ACTION
2021-08-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HALOPERIDOL DECANOATEDiscontinued
HALOPERIDOL DECANOATE EQ 100MG BASE/ML · INJECTABLE · INJECTION
HALOPERIDOL DECANOATEDiscontinued
HALOPERIDOL DECANOATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2021-08-23Labeling · Supplement 36 · standardAP
2020-06-25Labeling · Supplement 33 · standardAP
2019-08-12Labeling · Supplement 28 · standardAP
2019-08-12Labeling · Supplement 26 · standardAP
2019-08-12Manufacturing (CMC) · Supplement 32 · unknownAP
2019-08-12Labeling · Supplement 30 · standardAP
2019-08-12Labeling · Supplement 31 · standardAP
2016-01-05Labeling · Supplement 24 · standardAP
2012-05-01Labeling · Supplement 19AP
2010-05-06Labeling · Supplement 8AP
2009-04-30Labeling · Supplement 6AP
2006-06-13Labeling · Supplement 4AP
2003-07-30Labeling · Supplement 1AP
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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