APPLICATION
ANDA089903
TYPE
ANDA
ORIGINAL APPROVAL
1989-08-29
LATEST ACTION
2025-02-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCHLORPERAZINE EDISYLATEPrescription
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-02-19Labeling · Supplement 33 · standardAP
2017-03-21Labeling · Supplement 21 · standardAP
2016-08-26Labeling · Supplement 20 · standardAP
2009-06-29Labeling · Supplement 17AP
2008-11-25Labeling · Supplement 16AP
2004-07-14Labeling · Supplement 10AP
2002-11-13Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
1999-10-07Manufacturing (CMC) · Supplement 7AP
1997-08-12Manufacturing (CMC) · Supplement 6AP
1996-08-01Manufacturing (CMC) · Supplement 5AP
1993-11-18Manufacturing (CMC) · Supplement 4AP
1993-09-01Labeling · Supplement 3AP
1992-09-28Manufacturing (CMC) · Supplement 2AP
1989-09-15Labeling · 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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