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FDA NDA · NDA010742

COMPAZINE

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APPLICATION
NDA010742
TYPE
NDA
ORIGINAL APPROVAL
1957-04-08
LATEST ACTION
2001-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

COMPAZINE · ReferenceDiscontinued
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2001-04-03Labeling · Supplement 65 · standardLetterAP
1979-08-21Labeling · Supplement 31AP
1957-04-08Type 2 - New Active Ingredient · Original · standardAP
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