APPLICATION
ANDA040540
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-28
LATEST ACTION
2025-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCHLORPERAZINE EDISYLATEPrescription
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-03-19Labeling · Supplement 17 · standardAP
2025-01-22Labeling · Supplement 20 · standardAP
2019-03-11Manufacturing (CMC) · Supplement 16AP
2010-12-03Labeling · Supplement 9AP
2009-08-17Labeling · Supplement 8AP
2009-03-12Labeling · Supplement 7AP
2008-09-03Labeling · Supplement 5AP
2007-09-25Labeling · Supplement 3AP
2004-05-28OriginalAP
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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