← FDA DRUG APPROVALS

FDA NDA · NDA019734

CARDENE IV

nicardipine hydrochloride

Sponsor: CHIESI

APPLICATION
NDA019734
TYPE
NDA
ORIGINAL APPROVAL
1992-01-30
LATEST ACTION
2026-03-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER · ReferencePrescription
NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) · INJECTABLE · INTRAVENOUS
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) · INJECTABLE · INTRAVENOUS
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) · INJECTABLE · INTRAVENOUS
CARDENE · ReferencePrescription
NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) · INJECTABLE · INJECTION
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-03-27Labeling · Supplement 36 · standard — Label ↗AP
2025-02-21Labeling · Supplement 34 · standard — Letter ↗AP
2022-09-16Labeling · Supplement 31 · standard — Letter ↗AP
2018-07-27Labeling · Supplement 30 · standard — Letter ↗AP
2016-08-26Labeling · Supplement 27 · standard — Letter ↗AP
2015-12-21Manufacturing (CMC) · Supplement 26 · standardAP
2015-05-21Manufacturing (CMC) · Supplement 25 · standardAP
2014-12-02Manufacturing (CMC) · Supplement 24 · standardAP
2014-07-23Labeling · Supplement 23 · standard — Label ↗AP
2014-04-30Manufacturing (CMC) · Supplement 22 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 21 · standardAP
2013-05-02Manufacturing (CMC) · Supplement 20 · standardAP
2011-02-07Labeling · Supplement 17 · standard — Letter ↗AP
2010-01-13Labeling · Supplement 15 · standard — Letter ↗AP
2008-11-07Manufacturing (CMC) · Supplement 14 — Review ↗AP
2008-07-31Manufacturing (CMC) · Supplement 13 — Review ↗AP
2007-06-22Labeling · Supplement 9 · standard — Letter ↗AP
2002-10-24Manufacturing (CMC) · Supplement 5 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 4 · standardAP
1995-05-12Manufacturing (CMC) · Supplement 2 · standardAP
1995-04-10Manufacturing (CMC) · Supplement 3 · standardAP
1992-11-20Manufacturing (CMC) · Supplement 1 · standardAP
1992-01-30Type 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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