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FDA NDA · NDA011000

COMPAZINE

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APPLICATION
NDA011000
TYPE
NDA
ORIGINAL APPROVAL
1957-06-05
LATEST ACTION
2001-04-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

COMPAZINEDiscontinued
PROCHLORPERAZINE MALEATE EQ 75MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
COMPAZINEDiscontinued
PROCHLORPERAZINE MALEATE EQ 15MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
COMPAZINEDiscontinued
PROCHLORPERAZINE MALEATE EQ 30MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
COMPAZINEDiscontinued
PROCHLORPERAZINE MALEATE EQ 10MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2001-04-03Labeling · Supplement 84 · standard — Letter ↗AP
1979-08-21Labeling · Supplement 46AP
1957-06-05Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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