Cardene Sr

NDA 20005, held by Chiesi. Nicardipine Hydrochloride.

As of Nov 14, 2026, NDA 20005 (Cardene Sr), held by Chiesi, was first approved by FDA on Feb 21, 1992, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 21, 1992
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 21, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Cardene Sr30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Nicardipine Hydrochloride	DiscontinuedReference drug
Cardene Sr45MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Nicardipine Hydrochloride	DiscontinuedReference drug
Cardene Sr60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Nicardipine Hydrochloride	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Aug 29, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Jul 30, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 9, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 29, 1999	Supplement 5Labeling · Standard review	Approved	None posted
Jan 7, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 22, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 4, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Nov 20, 1992	Supplement 1Labeling · Standard review	Approved	None posted
Feb 21, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20005
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