APPLICATION
ANDA209101
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-03
LATEST ACTION
2021-11-12
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HALOPERIDOL DECANOATEPrescription
HALOPERIDOL DECANOATE EQ 100MG BASE/ML · INJECTABLE · INJECTION
HALOPERIDOL DECANOATEPrescription
HALOPERIDOL DECANOATE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2021-11-12Labeling · Supplement 8 · standardAP
2021-11-12Labeling · Supplement 6 · standardAP
2021-11-12Labeling · Supplement 11 · standardAP
2021-11-12Labeling · Supplement 7 · standardAP
2021-11-12Labeling · Supplement 5 · standardAP
2019-04-04Labeling · Supplement 1 · standardAP
2019-04-04Labeling · Supplement 2 · standardAP
2018-07-03UNKNOWN · Original · standardAP
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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