APPLICATION
ANDA204147
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-15
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCHLORPERAZINE EDISYLATEPrescription
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-01-22Labeling · Supplement 36 · standardAP
2020-06-25Labeling · Supplement 25 · standardAP
2019-09-09Manufacturing (CMC) · Supplement 21 · standardAP
2017-02-23Labeling · Supplement 9 · standardAP
2013-10-15UNKNOWN · OriginalAP
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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