APPLICATION
ANDA040185
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-28
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROCHLORPERAZINE MALEATEDiscontinued
PROCHLORPERAZINE MALEATE EQ 10MG BASE · TABLET · ORAL
PROCHLORPERAZINE MALEATEDiscontinued
PROCHLORPERAZINE MALEATE EQ 5MG BASE · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 17 · standardAP
2017-02-23Labeling · Supplement 13 · standardAP
2010-12-03Labeling · Supplement 12AP
2009-07-22Labeling · Supplement 11AP
2008-11-19Labeling · Supplement 9AP
2008-05-29Labeling · Supplement 8AP
2006-06-22Labeling · Supplement 5AP
2002-12-13Manufacturing (CMC) · Supplement 3AP
2002-12-09Labeling · Supplement 2AP
1998-02-05Manufacturing (CMC) · Supplement 1AP
1996-10-28OriginalAP
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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