FDA ANDA · ANDA040268

PROCHLORPERAZINE MALEATE

Sponsor: JUBILANT CADISTA

APPLICATION

ANDA040268

TYPE

ANDA

ORIGINAL APPROVAL

1998-02-27

LATEST ACTION

2025-01-22

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

PROCOMPPrescription

PROCHLORPERAZINE MALEATE EQ 10MG BASE · TABLET · ORAL

PROCOMPPrescription

PROCHLORPERAZINE MALEATE EQ 5MG BASE · TABLET · ORAL

2025-01-22Labeling · Supplement 33 · standard — Label ↗AP

2017-02-23Labeling · Supplement 21 · standardAP

2010-12-03Labeling · Supplement 16AP

2010-01-14Labeling · Supplement 12AP

2009-08-18Labeling · Supplement 15AP

2009-07-15Labeling · Supplement 14AP

2009-04-30Labeling · Supplement 13AP

2008-12-18Labeling · Supplement 11AP

2008-09-03Labeling · Supplement 9AP

2006-06-07Labeling · Supplement 5AP

2004-04-20Labeling · Supplement 3AP

1998-11-16Manufacturing (CMC) · Supplement 1AP

1998-02-27Original — Review ↗AP

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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