← FDA DRUG APPROVALS

FDA NDA · NDA022156

CLEVIPREX

clevidipine

Sponsor: CHIESI

APPLICATION
NDA022156
TYPE
NDA
ORIGINAL APPROVAL
2008-08-01
LATEST ACTION
2021-04-16
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription, Discontinued

Products

CLEVIPREX · ReferencePrescription
CLEVIDIPINE 50MG/100ML (0.5MG/ML) · EMULSION · INTRAVENOUS
CLEVIPREX · ReferenceDiscontinued
CLEVIDIPINE 125MG/250ML (0.5MG/ML) · EMULSION · INTRAVENOUS
CLEVIPREX · ReferencePrescription
CLEVIDIPINE 25MG/50ML (0.5MG/ML) · EMULSION · INTRAVENOUS

Approval history

2021-04-16Labeling · Supplement 7 · standard — Label ↗AP
2015-06-23Manufacturing (CMC) · Supplement 5 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 4 · standardAP
2011-12-08Labeling · Supplement 3 · unknown — Label ↗AP
2008-08-01Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
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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