Cardene, Cardene In 4.8% Dextrose In Plastic Container, Cardene In 0.86% Sodium Chloride In Plastic Container

Treats hypertension. NDA 19734, held by Chiesi. Nicardipine Hydrochloride.

As of Nov 13, 2026, NDA 19734 (Cardene, Cardene In 4.8% Dextrose In Plastic Container, Cardene In 0.86% Sodium Chloride In Plastic Container), held by Chiesi, was first approved by FDA on Jan 30, 1992, with 22 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1992
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension in adults when oral therapy is not feasible. 1.1 Hypertension CARDENE I.V. (nicardipine hydrochloride) is indicated in adults for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jan 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

5 strengths and forms


Cardene25MG/10ML (2.5MG/ML) · injectable;injection	Nicardipine Hydrochloride	RxReference drug
Cardene In 4.8% Dextrose In Plastic Container20MG/200ML (0.1MG/ML) · injectable;intravenous	Nicardipine Hydrochloride	RxReference drug
Cardene In 0.86% Sodium Chloride In Plastic Container20MG/200ML (0.1MG/ML) · injectable;intravenous	Nicardipine Hydrochloride	RxReference drug
Cardene In 0.83% Sodium Chloride In Plastic Container40MG/200ML (0.2MG/ML) · injectable;intravenous	Nicardipine Hydrochloride	RxReference drug
Cardene In 5.0% Dextrose In Plastic Container40MG/200ML (0.2MG/ML) · injectable;intravenous	Nicardipine Hydrochloride	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Mar 27, 2026	Supplement 36Labeling · Standard review	Approved	Letter Label
Feb 21, 2025	Supplement 34Labeling · Standard review	Approved	Letter Label
Sep 16, 2022	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 27, 2018	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 26, 2016	Supplement 27Labeling · Standard review	Approved	Letter Label
Dec 21, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
May 21, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 2, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 23, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 30, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 27, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
May 2, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 7, 2011	Supplement 17Labeling · Standard review	Approved	Letter Label
Jan 13, 2010	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 7, 2008	Supplement 14Manufacturing	Approved	Letter Review
Jul 31, 2008	Supplement 13Manufacturing	Approved	Letter Review
Jun 22, 2007	Supplement 9Labeling · Standard review	Approved	Letter
Oct 24, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
May 12, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 10, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 20, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 30, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19734
Drugs@FDA: Overview at FDA
Company: Chiesi

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters