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FDA ANDA · ANDA040207

PROCHLORPERAZINE MALEATE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040207
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-01
LATEST ACTION
2002-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROCHLORPERAZINE MALEATEDiscontinued
PROCHLORPERAZINE MALEATE EQ 5MG BASE · TABLET · ORAL
PROCHLORPERAZINE MALEATEDiscontinued
PROCHLORPERAZINE MALEATE EQ 10MG BASE · TABLET · ORAL

Approval history

2002-12-12Labeling · Supplement 5AP
2002-05-08Manufacturing (CMC) · Supplement 4AP
2002-05-08Manufacturing (CMC) · Supplement 2AP
2002-05-08Manufacturing (CMC) · Supplement 3AP
1998-10-20Manufacturing (CMC) · Supplement 1AP
1997-05-01Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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