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FDA NDA · NDA010571

COMPAZINE

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APPLICATION
NDA010571
TYPE
NDA
ORIGINAL APPROVAL
1956-10-23
LATEST ACTION
2005-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE MALEATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE MALEATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE MALEATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2005-08-03Labeling · Supplement 96 · standard — Letter ↗AP
2001-04-03Labeling · Supplement 95 · standard — Letter ↗AP
1992-09-30Manufacturing (CMC) · Supplement 86 · priorityAP
1979-08-21Labeling · Supplement 58AP
1956-10-23Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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