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FDA NDA · NDA021369

CODEPREX

Sponsor: LANNETT CO INC

APPLICATION
NDA021369
TYPE
NDA
ORIGINAL APPROVAL
2004-06-21
LATEST ACTION
2004-06-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CODEPREXDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 4MG MALEATE/5ML, CODEINE POLISTIREX EQ 20MG BASE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2004-06-21Type 3 - New Dosage Form · Original · standardReviewAP
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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