APPLICATION
ANDA089530
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-08
LATEST ACTION
2017-02-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCHLORPERAZINE EDISYLATEDiscontinued
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2017-02-23Labeling · Supplement 14 · standardAP
2015-11-03Labeling · Supplement 13AP
1999-02-19Manufacturing (CMC) · Supplement 10AP
1999-02-02Manufacturing (CMC) · Supplement 9AP
1996-12-04Manufacturing (CMC) · Supplement 8AP
1993-10-19Labeling · Supplement 7AP
1992-05-11Labeling · Supplement 6AP
1991-08-12Labeling · Supplement 5AP
1991-03-20Labeling · Supplement 4AP
1989-04-18Manufacturing (CMC) · Supplement 3AP
1988-06-02Labeling · Supplement 1AP
1987-07-08OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.