APPLICATION
ANDA040162
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-20
LATEST ACTION
2002-07-29
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
2002-07-29Manufacturing (CMC) · Supplement 11AP
2001-09-12Manufacturing (CMC) · Supplement 9AP
2000-11-13Manufacturing (CMC) · Supplement 7AP
2000-11-13Manufacturing (CMC) · Supplement 8AP
2000-10-17Labeling · Supplement 6AP
2000-05-01Manufacturing (CMC) · Supplement 5AP
2000-05-01Manufacturing (CMC) · Supplement 4AP
2000-01-28Manufacturing (CMC) · Supplement 3AP
1999-11-23Manufacturing (CMC) · Supplement 2AP
1998-12-09Manufacturing (CMC) · 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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