APPLICATION
ANDA040120
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-11
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 18 · standardAP
2017-02-23Labeling · Supplement 14 · standardAP
2010-12-03Labeling · Supplement 13AP
2009-07-22Labeling · Supplement 11AP
2008-11-19Labeling · Supplement 10AP
2008-05-15Labeling · Supplement 9AP
2006-06-22Labeling · Supplement 8AP
2001-06-25Manufacturing (CMC) · Supplement 7AP
2001-06-25Manufacturing (CMC) · Supplement 5AP
2001-06-25Manufacturing (CMC) · Supplement 6AP
2000-12-07Manufacturing (CMC) · Supplement 3AP
2000-12-07Manufacturing (CMC) · Supplement 4AP
2000-12-07Manufacturing (CMC) · Supplement 2AP
1999-03-23Manufacturing (CMC) · Supplement 1AP
1996-07-11OriginalAP
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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